Reproduction of a conventional anthropomorphic female chest phantom by 3D-printing: Comparison of image contrasts and absorbed doses in CT.

BACKGROUND: The production of individualized anthropomorphic phantoms via three-dimensional (3D) printing methods offers promising possibilities to assess and optimize radiation exposures for specifically relevant patient groups (i.e., overweighed or pregnant persons) that are not adequately represented by standardized anthropomorphic phantoms. However, the equivalence of printed phantoms must be demonstrated exemplarily with respect to the resulting image contrasts and dose distributions. PURPOSE: To reproduce a conventionally produced anthropomorphic phantom of a female chest and breasts and to evaluate their equivalence with respect to image contrasts and absorbed doses at the example of a computed tomography (CT) examination of the chest. METHODS: In a first step, the effect of different print settings on the CT values of printed samples was systematically investigated. Subsequently, a transversal slice and breast add-ons of a conventionally produced female body phantom were reproduced using a multi-material extrusion-based printer, considering six different types of tissues (muscle, lung, adipose, and glandular breast tissue, as well as bone and cartilage). CT images of the printed and conventionally produced phantom parts were evaluated with respect to their geometric correspondence, image contrasts, and absorbed doses measured using thermoluminescent dosimeters. RESULTS: CT values of printed objects are highly sensitive to the selected print settings. The soft tissues of the conventionally produced phantom could be reproduced with a good agreement. Minor differences in CT values were observed for bone and lung tissue, whereas absorbed doses to the relevant tissues were identical within the measurement uncertainties. CONCLUSION: 3D-printed phantoms are with exception of minor contrast differences equivalent to their conventionally manufactured counterparts. When comparing the two production techniques, it is important to note that conventionally manufactured phantoms should not be considered as absolute benchmarks, as they also only approximate the human body in terms of its absorption, and attenuation of x-rays as well as its geometry.

Improving pulmonary perfusion assessment by dynamic contrast-enhanced computed tomography in an experimental lung injury model.

Pulmonary perfusion has been poorly characterized in acute respiratory distress syndrome (ARDS). Optimizing protocols to measure pulmonary blood flow (PBF) via dynamic contrast-enhanced (DCE) computed tomography (CT) could improve understanding of how ARDS alters pulmonary perfusion. In this study, comparative evaluations of injection protocols and tracer-kinetic analysis models were performed based on DCE-CT data measured in ventilated pigs with and without lung injury. Ten Yorkshire pigs (five with lung injury, five healthy) were anesthetized, intubated, and mechanically ventilated; lung injury was induced by bronchial hydrochloric acid instillation. Each DCE-CT scan was obtained during a 30-s end-expiratory breath-hold. Reproducibility of PBF measurements was evaluated in three pigs. In eight pigs, undiluted and diluted Isovue-370 were separately injected to evaluate the effect of contrast viscosity on estimated PBF values. PBF was estimated with the peak-enhancement and the steepest-slope approach. Total-lung PBF was estimated in two healthy pigs to compare with cardiac output measured invasively by thermodilution in the pulmonary artery. Repeated measurements in the same animals yielded a good reproducibility of computed PBF maps. Injecting diluted isovue-370 resulted in smaller contrast-time curves in the pulmonary artery (P < 0.01) and vein (P < 0.01) without substantially diminishing peak signal intensity (P = 0.46 in the pulmonary artery) compared with the pure contrast agent since its viscosity is closer to that of blood. As compared with the peak-enhancement model, PBF values estimated by the steepest-slope model with diluted contrast were much closer to the cardiac output (R2 = 0.82) as compared with the peak-enhancement model. DCE-CT using the steepest-slope model and diluted contrast agent provided reliable quantitative estimates of PBF.NEW & NOTEWORTHY Dynamic contrast-enhanced CT using a lower-viscosity contrast agent in combination with tracer-kinetic analysis by the steepest-slope model improves pulmonary blood flow measurements and assessment of regional distributions of lung perfusion.

Dose-efficiency quantification of computed tomography systems using a model-observer.

BACKGROUND: Recent advances in computed tomography (CT) technology have considerably improved the quality of CT images and reduced radiation exposure in patients. At present, however, there is no generally accepted figure of merit (FOM) for comparing the dose efficiencies of CT systems. PURPOSE: (i) To establish an FOM that characterizes the quality of CT images in relation to the radiation dose by means of a mathematical model observer and (ii) to evaluate the new FOM on different CT systems and image reconstruction algorithms. METHODS: Images of a homogeneous phantom with four low-contrast inserts were acquired using three different CT systems at three dose levels and a representative protocol for CT imaging of low-contrast objects in the abdomen. The images were reconstructed using filtered-back projection and iterative algorithms. A channelized hotelling observer with difference-of-Gaussian channels was applied to compute the detectability ( d ' $d^{\prime}$ ). This was done for each insert and each of the considered imaging conditions from square regions of interest (ROIs) that were (semi-)automatically centered on the inserts. The estimated detectabilities ( d ' $d^{\prime}$ ) were averaged in the first step over the three dose levels ( ⟨ d ' ⟩ $\langle {d^{\prime}} \rangle $ ), and subsequently over the four contrast inserts ( ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ ). All calculation steps included a dedicated assessment of the related uncertainties following accepted metrological guidelines. RESULTS: The determined detectabilities ( d ' $d^{\prime}$ ) varied considerably with the contrast and diameter of the four inserts, as well as with the radiation doses and reconstruction algorithms used for image generation ( d ' $d^{\prime}\;$ = 1.3-5.5). Thus, the specification of a single detectability as an FOM is not well suited for comprehensively characterizing the dose efficiency of a CT system. A more comprehensive and robust characterization was provided by the averaged detectabilities ⟨ d ' ⟩ $\langle {d^{\prime}} \rangle $ and, in particular, ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ . Our analysis reveals that the model observer analysis is very sensitive to the exact position of the ROIs. CONCLUSIONS: The presented automatable software approach yielded with the weighted detectability ⟨ d ' ⟩ w ${\langle {d^{\prime}} \rangle _{\rm{w}}}$ an objective FOM to benchmark different CT systems and reconstruction algorithms in a robust and reliable manner. An essential advantage of the proposed model-observer approach is that uncertainties in the FOM can be provided, which is an indispensable prerequisite for type testing.

Tissue equivalence of 3D printing materials with respect to attenuation and absorption of X-rays used for diagnostic and interventional imaging.

INTRODUCTION: Three-dimensional printing is a promising technology to produce phantoms for quality assurance and dosimetry in X-ray imaging. Crucial to this, however, is the use of tissue equivalent printing materials. It was thus the aim of this study to evaluate the properties of a larger number of commercially available printing filaments with respect to their attenuation and absorption of X-rays. MATERIALS AND METHODS: Apparent kerma attenuation coefficients (AKACs) and absorbed doses for different X-ray spectra (tube voltages, 70-140 kV) were measured and simulated by Monte-Carlo computations for a larger number of fused-deposition-modeling (FDM) materials. The results were compared with the respective values simulated for reference body tissues. In addition, the properties of polylactide acid samples printed with reduced infill densities were investigated. RESULTS: Measured and simulated AKACs and absorbed doses agreed well with each other and in case of AKACs also with attenuation coefficients derived from the reference database of the National Institute of Standards and Technology (NIST). For lung, adipose, muscle, and bulk soft tissue as well as for spongiosa (cancellous bone), printed materials with equivalent attenuation as well as absorption properties could be identified. In contrast, none of the considered printed materials was equivalent to cortical bone. CONCLUSION: Several FDM materials have been identified as well-suited substitutes for body tissues in terms of the investigated material characteristics. They can therefore be used for in-house production of individualized and task-specific phantoms for image quality assessment and dose measurements in X-ray imaging.

Lung Cancer Screening with Low-Dose CT: Radiation Risk and Benefit-Risk Assessment for Different Screening Scenarios.

Lung cancer is a severe disease that affects predominantly smokers and represents a leading cause of cancer death in Europe. Recent meta-analyses of randomized controlled trials (RCTs) have yielded that low-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in heavy smokers or ex-smokers by about 20% compared to a control group of persons who did not receive LDCT. This benefit must be weighed against adverse health effects associated with LDCT lung screening, in particular radiation risks. For this purpose, representative organ doses were determined for a volume CT dose index of 1 mGy that can be achieved on modern devices. Using these values, radiation risks were estimated for different screening scenarios by means of sex-, organ-, and age-dependent radio-epidemiologic models. In particular, the approach was adjusted to a Western European population. For an annual LDCT screening of (ex-)smokers aged between 50 and 75 years, the estimated radiation-related lifetime attributable risk to develop cancer is below 0.25% for women and about 0.1% for men. Assuming a mortality reduction of about 20% and taking only radiation risks into account, this screening scenario results in a benefit-risk ratio of about 10 for women and about 25 for men. These benefit-risk ratio estimates are based on the results of RCTs of the highest evidence level. To ensure that the benefit outweighs the radiation risk even in standard healthcare, strict conditions and requirements must be established for the entire screening process to achieve a quality level at least as high as that of the considered RCTs.

Lung Cancer Screening with Low-Dose CT in Smokers: A Systematic Review and Meta-Analysis.

Lung cancer continues to be one of the main causes of cancer death in Europe. Low-dose computed tomography (LDCT) has shown high potential for screening of lung cancer in smokers, most recently in two European trials. The aim of this review was to assess lung cancer screening of smokers by LDCT with respect to clinical effectiveness, radiological procedures, quality of life, and changes in smoking behavior. We searched electronic databases in April 2020 for publications of randomized controlled trials (RCT) reporting on lung cancer and overall mortality, lung cancer morbidity, and harms of LDCT screening. A meta-analysis was performed to estimate effects on mortality. Forty-three publications on 10 RCTs were included. The meta-analysis of eight studies showed a statistically significant relative reduction of lung cancer mortality of 12% in the screening group (risk ratio = 0.88; 95% CI: 0.79-0.97). Between 4% and 24% of screening-LDCT scans were classified as positive, and 84-96% of them turned out to be false positive. The risk of overdiagnosis was estimated between 19% and 69% of diagnosed lung cancers. Lung cancer screening can reduce disease-specific mortality in (former) smokers when stringent requirements and quality standards for performance are met.

COPD Imaging on a 3rd Generation Dual-Source CT: Acquisition of Paired Inspiratory-Expiratory Chest Scans at an Overall Reduced Radiation Risk.

As stated by the Fleischner Society, an additional computed tomography (CT) scan in expiration is beneficial in patients with chronic obstructive pulmonary disease (COPD). It was thus the aim of this study to evaluate the radiation risk of a state-of-the-art paired inspiratory-expiratory chest scan compared to inspiration-only examinations. Radiation doses to 28 organs were determined for 824 COPD patients undergoing routine chest examinations at three different CT systems-a conventional multi-slice CT (MSCT), a 2nd generation (2nd-DSCT), and 3rd generation dual-source CT (3rd-DSCT). Patients examined at the 3rd-DSCT received a paired inspiratory-expiratory scan. Organ doses, effective doses, and lifetime attributable cancer risks (LAR) were calculated. All organ and effective doses were significantly lower for the paired inspiratory-expiratory protocol (effective doses: 4.3 ± 1.5 mSv (MSCT), 3.0 ± 1.2 mSv (2nd-DSCT), and 2.0 ± 0.8 mSv (3rd-DSCT)). Accordingly, LAR was lowest for the paired protocol with an estimate of 0.025 % and 0.013% for female and male patients (50 years) respectively. Image quality was not compromised. Paired inspiratory-expiratory scans can be acquired on 3rd-DSCT systems at substantially lower dose and risk levels when compared to inspiration-only scans at conventional CT systems, offering promising prospects for improved COPD diagnosis.

Double-strand breaks in lymphocyte DNA of humans exposed to [18F]fluorodeoxyglucose and the static magnetic field in PET/MRI.

BACKGROUND: Given the increasing clinical use of PET/MRI, potential risks to patients from simultaneous exposure to ionising radiation and (electro)magnetic fields should be thoroughly investigated as a precaution. With this aim, the genotoxic potential of 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG) and a strong static magnetic field (SMF) were evaluated both in isolation and in combination using the γH2AX assay detecting double-strand breaks in lymphocyte DNA. METHODS: Thirty-two healthy young volunteers allocated to three study arms were exposed to [18F]FDG alone, to a 3-T SMF alone or to both combined over 60 min at a PET/CT or a PET/MRI system. Blood samples taken after in vivo exposure were incubated up to 60 min to extend the irradiation of blood by residual [18F]FDG within the samples and the time to monitor the γH2AX response. Absorbed doses to lymphocytes delivered in vivo and in vitro were estimated individually for each volunteer exposed to [18F]FDG. γH2AX foci were scored automatically by immunofluorescence microscopy. RESULTS: Absorbed doses to lymphocytes exposed over 60 to 120 min to [18F]FDG varied between 1.5 and 3.3 mGy. In this time interval, the radiotracer caused a significant median relative increase of 28% in the rate of lymphocytes with at least one γH2AX focus relative to the background rate (p = 0.01), but not the SMF alone (p = 0.47). Simultaneous application of both agents did not result in a significant synergistic or antagonistic outcome (p = 0.91). CONCLUSION: There is no evidence of a synergism between [18F]FDG and the SMF that may be of relevance for risk assessment of PET/MRI.

Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. / Früherkennung von Krankheiten mittels radiologischer Bildgebung: Neue Rechtslage und Bewertung von Leistungsangeboten am Beispiel von CT-Untersuchungen.

BACKGROUND: Radiological imaging offers promising prospects for the early detection of diseases. In Germany, the legal framework for such examinations was created by the Radiation Protection Law, which entered into force on December 31, 2018. Under this law, each specific type of radiodiagnostic screening of non-communicable diseases needs an approval on a generic level (permission) by a federal statutory ordinance, defining the specific requirements and conditions. It is the aim of the present paper, (i) to present in detail the new legal situation and (ii) to assess actual service offers for the screening of asymptomatic persons using CT examinations as an example. METHOD: In February 2019, radiology institutions in Germany illegally offering on the Internet CT examinations for the screening of lung and colon cancer or coronary artery disease were identified. For each type of examination, 50 pertinent websites were evaluated particularly regarding the general information on the offered screening examination and the concrete procedure. RESULTS: In the vast majority of cases, the information provided on the websites was inadequate and disproportionately emphasized the benefits over the risks of the screening examination. Moreover, the offers differed substantially with respect to the age and risks factors of potential participants, the frequency of examinations, the screening procedure, and the diagnostic workup. CONCLUSION: The evaluated service offers strongly substantiate the need to define requirements and conditions regarding radiological screening examinations by statutory ordinances, in order to ensure an informed decision of potential screening participants as well as the benefit versus the risks of the procedures. KEY POINTS: · High-evidence studies prove the benefit of radiological screening for some diseases.. · In Germany, screening examinations are only permissible when stated in a federal statutory ordinance.. · At present, only mammography screening for breast cancer is permitted in Germany.. · CT screening examinations currently being conducted in Germany do not fulfill the legal and professional requirements.. · A review process has been initiated regarding possible generic approval of lung cancer screening.. CITATION FORMAT: · Brix G, Nekolla EA, Griebel J. Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example. Fortschr Röntgenstr 2020; 192: 139 - 148.

Diagnostic Reference Levels for Diagnostic and Interventional X-Ray Procedures in Germany: Update and Handling. / Diagnostische Referenzwerte für diagnostische und interventionelle Röntgenanwendungen in Deutschland: Aktualisierung und Handhabung.

PURPOSE: Recent developments in medical technology have broadened the spectrum of X-ray procedures and changed exposure practice in X-ray facilities. For this reason, diagnostic reference levels (DRLs) for diagnostic and interventional X-ray procedures were updated in 2016 and 2018, respectively. It is the aim of this paper to present the procedure for the update of the DRLs and to give advice on their practical application. MATERIALS AND METHODS: For the determination of DRLs, data from different independent sources that collect dose-relevant data from different facilities in Germany were considered. Seven different weight intervals were specified for classifying pediatric X-ray procedures. For each X-ray procedure considered, the 25th, 50th, and 75th percentile of the respective national distribution of the dose-relevant parameters were determined. Additionally, effective doses that correspond to the DRLs were estimated. RESULTS: In procedures with already existing DRLs before 2016, the values were lowered by circa 20 % on average. Numerous DRLs were established for the first time (9 for interventional procedures, 10 for CT examinations). CONCLUSION: For dose optimizations even below the new national DRLs, the BfS recommends establishing local reference levels, using dose management software (particularly in CT and interventional radiology), adapting dose-relevant parameters of X-ray protocols to the individual patient size, and establishing internal radiation protection teams responsible for optimizing X-ray procedures in clinical practice. When applying good medical practice and using modern equipment, the median dose values of the nationwide dose distributions can not only be easily achieved but can even be undercut. KEY POINTS: · German diagnostic reference levels (DRLs) für diagnostic and interventional X-ray procedures were updated in 2016 and 2018, respectively.. · For X-ray procedures for which DRLs existed already before the update, the updated DLRs were lowered by circa 20 %, on average.. · For CT and interventional radiology, new DRLs were established.. · X-ray procedures have to be optimized even below the DRLs.. CITATION FORMAT: · Schegerer A, Loose R, Heuser LJ et al. Diagnostic Reference Levels for Diagnostic and Interventional X-Ray Procedures in Germany: Update and Handling. Fortschr Röntgenstr 2019; 191: 739 - 751.

[Reporting and information system for significant events related to radiation exposures in medicine: Structure, responsibilities and reporting criteria]. / Melde- und Informationssystem für bedeutsame Vorkommnisse bei Strahlenanwendungen in der Medizin: Struktur, Zuständigkeiten und Meldekriterien.

The increasing frequency and complexity of medical radiation exposures to humans inevitably result in higher risks of harmful unintended or accidental radiation exposures. To ensure a high level of protection and its continuous improvement, the Directive 2013/59/Euratom thus requires to systematically record and analyze both events and near-miss events as well as, in the case of their significance, to disseminate information regarding lessons learned from these events promptly and nationwide to improve radiation protection in medicine. These requirements have been transposed into German legislation by the new radiation protection law and radiation protection ordinance that entered into force simultaneously on December 31th, 2018. The reporting and information system as provided by these regulations as well as the tasks, duties and powers of the parties involved are presented in the first part of this review article. In the second part, the established application-specified criteria for the significance - and thus the notification requirement - of (near-miss) events are itemized and explicated.

Current CT practice in Germany: Results and implications of a nationwide survey.

PURPOSE: To assess patient doses and relative frequencies of standard CT examinations performed in Germany in 2013/14 as well as the effect of modern CT technology on patient exposure. METHODS: All known CT facilities in Germany were requested to complete a questionnaire on the frequency of 34 examinations and the respective parameter settings used. Taking into account type-specific properties of each scanner, effective doses were estimated for each reported examination. The mean and the percentiles of the CT dose index, scan length, dose length product, and effective dose were determined for each type of examination. RESULTS: According to the data provided for about 11% of all medical CT scanners operated in 2013/14, the effective dose was 4.6/5.9mSv per scan/examination. The effective dose was significantly reduced by about 15% compared to the CT practice before 2010. Modern CT technology, such as tube current modulation and iterative image reconstruction reduced the effective dose significantly by 6% and 13%, respectively. The mean effective dose applied at scanners produced by different manufacturers differed by 25%, at maximum. CONCLUSION: Patient exposure was reduced substantially in recent years. There is, however, still a considerable potential for further dose reduction by adapting scan protocols to the medical purpose and by a consequent exploitation of modern CT technologies.

Two-compartment modeling of tissue microcirculation revisited.

PURPOSE: Conventional two-compartment modeling of tissue microcirculation is used for tracer kinetic analysis of dynamic contrast-enhanced (DCE) computed tomography or magnetic resonance imaging studies although it is well-known that the underlying assumption of an instantaneous mixing of the administered contrast agent (CA) in capillaries is far from being realistic. It was thus the aim of the present study to provide theoretical and computational evidence in favor of a conceptually alternative modeling approach that makes it possible to characterize the bias inherent to compartment modeling and, moreover, to approximately correct for it. METHODS: Starting from a two-region distributed-parameter model that accounts for spatial gradients in CA concentrations within blood-tissue exchange units, a modified lumped two-compartment exchange model was derived. It has the same analytical structure as the conventional two-compartment model, but indicates that the apparent blood flow identifiable from measured DCE data is substantially overestimated, whereas the three other model parameters (i.e., the permeability-surface area product as well as the volume fractions of the plasma and interstitial distribution space) are unbiased. Furthermore, a simple formula was derived to approximately compute a bias-corrected flow from the estimates of the apparent flow and permeability-surface area product obtained by model fitting. To evaluate the accuracy of the proposed modeling and bias correction method, representative noise-free DCE curves were analyzed. They were simulated for 36 microcirculation and four input scenarios by an axially distributed reference model. RESULTS: As analytically proven, the considered two-compartment exchange model is structurally identifiable from tissue residue data. The apparent flow values estimated for the 144 simulated tissue/input scenarios were considerably biased. After bias-correction, the deviations between estimated and actual parameter values were (11.2 ± 6.4) % (vs. (105 ± 21) % without correction) for the flow, (3.6 ± 6.1) % for the permeability-surface area product, (5.8 ± 4.9) % for the vascular volume and (2.5 ± 4.1) % for the interstitial volume; with individual deviations of more than 20% being the exception and just marginal. Increasing the duration of CA administration only had a statistically significant but opposite effect on the accuracy of the estimated flow (declined) and intravascular volume (improved). CONCLUSIONS: Physiologically well-defined tissue parameters are structurally identifiable and accurately estimable from DCE data by the conceptually modified two-compartment model in combination with the bias correction. The accuracy of the bias-corrected flow is nearly comparable to that of the three other (theoretically unbiased) model parameters. As compared to conventional two-compartment modeling, this feature constitutes a major advantage for tracer kinetic analysis of both preclinical and clinical DCE imaging studies.

Cumulative radiation exposure from imaging procedures and associated lifetime cancer risk for patients with lymphoma.

The aim of this study was to systematically evaluate the cumulative radiation exposure and the associated lifetime-cancer-risk from diagnostic imaging in patients with Hodgkin-lymphoma-(HL) or diffuse-large-B-cell-lymphoma (DLBCL). 99 consecutive patients (53-males) diagnosed with HL or DLBCL were included in the study and followed. Based on the imaging reports, organ and effective-doses-(ED) were calculated individually for each patient and the excess lifetime risks were estimated. The average ED in the first year after diagnosis was significantly different for men (59 ± 33 mSv) and women (74 ± 33 mSv)-(p < 0.05). The mean cumulative ED in each of the following 5 years was 16 ± 16 mSv without significant differences between men and women-(p > 0.05). Over all years, more than 90% of the ED resulted from CT. The average cumulative radiation risk estimated for the first year was significantly lower for men (0.76 ± 0.41%) as compared to women (1.28 ± 0.54%)-(p < 0.05). The same was found for each of the subsequent 5-years (men-0.18 ± 0.17%; women-0.28 ± 0.25%)-(p < 0.05). In conclusion, for HL and DLBCL patients investigated in this study, a cumulative radiation risk of about 1 excess cancer per 100 patients is estimated for diagnostic imaging procedures performed during both the first year after diagnosis and a follow-up period of 5 years.

Spectral optimization of iodine-enhanced CT: Quantifying the effect of tube voltage on image quality and radiation exposure determined at an anthropomorphic phantom.

PURPOSE: To provide an experimental basis for spectral optimization of iodine-enhanced CT by a quantitative analysis of image quality and radiation dose characteristics consistently measured for a large variety of scan settings at an anthropomorphic phantom. METHODS: CT imaging and thermoluminescent dosimetry were performed at an anthropomorphic whole-body phantom with iodine inserts for different tube voltages (U, 70-140kV) and current-time products (Q, 60-300mAs). For all U-Q combinations, the iodine contrast (C), the noise level (N) and, from these, the contrast-to-noise ratio (CNR) of reconstructed CT images were determined and parameterized as a function of U, Q or the measured absorbed dose (D). Finally, two characteristic curves were derived that give the relative increase of CNR at constant D and the relative decrease of D at constant CNR when lowering U. RESULTS: Lowering U affects the measured CNR only slightly but markedly reduces D. For example, reducing U from 120kV to 70kV increases the CNR at constant D by a factor of nearly 1.8 or, alternatively, reduces D at constant CNR by a factor of nearly 5. CONCLUSION: Spectral optimization by lowering U is an effective approach to attain the necessary CNR for a specific diagnostic task at hand while at the same time reducing radiation exposure as far as practically achievable. The characteristic curves derived in this study from extensive measurements at a reference 'person' can support CT users in an easy-to-use manner to select an appropriate voltage for various clinical scenarios.

[Approval procedures for clinical trials in the field of radiation oncology]. / Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie.

BACKGROUND AND PURPOSE: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. METHODS: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. RESULTS: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. CONCLUSION: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.

Multiple procedures and cumulative individual radiation exposure in interventional cardiology: A long-term retrospective study.

INTRODUCTION: Various studies address discrepancies between guideline recommendations for coronary angiographies and clinical practice. While the issue of the appropriateness of recurrent angiographies was studied focusing on the role of the cardiologist, little is known about individual patients' histories and the associated radiation exposures. METHODS: We analyzed all patients with coronary artery disease (CAD) in an academic teaching practice who underwent at least one angiography with or without intervention between 2004 and 2009. All performed angiographies in these patients were analyzed and rated by three physicians for appropriateness levels according to cardiology guidelines. Typical exposure data from the medical literature were used to estimate individual radiation exposure. RESULTS: In the cohort of 147 patients, a total of 441 procedures were analyzed: between 1981 and 2009, three procedures were performed per patient (range 1-19) on average. Appropriateness ratings were 'high/intermediate' in 71%, 'low/no' in 27.6% and data were insufficient for ratings in 1.4%. Procedures with 'low/no' ratings were associated with potentially avoidable exposures of up to 186 mSv for single patients. CONCLUSIONS: Using retrospective data, we exemplify the potential benefit of guideline adherence to decrease patients' radiation exposures. KEY POINTS: • A cohort study of 147 patients showed 27.6% low appropriateness procedures. • Potentially avoidable radiation exposure cumulated up to about 186 mSv for single patients. • Predisposing factors were prior bypass surgery and first treatment in a tertiary centre. • 7.5% of the patients received 58% of the potentially avoidable radiation exposure. • The benefits of guideline adherence in decreasing patient radiation exposure are exemplified.

Radiation protection issues in dynamic contrast-enhanced (perfusion) computed tomography.

Dynamic contrast-enhanced (DCE) CT studies are increasingly used in both medical care and clinical trials to improve diagnosis and therapy management of the most common life-threatening diseases: stroke, coronary artery disease and cancer. It is thus the aim of this review to briefly summarize the current knowledge on deterministic and stochastic radiation effects relevant for patient protection, to present the essential concepts for determining radiation doses and risks associated with DCE-CT studies as well as representative results, and to discuss relevant aspects to be considered in the process of justification and optimization of these studies. For three default DCE-CT protocols implemented at a latest-generation CT system for cerebral, myocardial and cancer perfusion imaging, absorbed doses were measured by thermoluminescent dosimeters at an anthropomorphic body phantom and compared with thresholds for harmful (deterministic) tissue reactions. To characterize stochastic radiation risks of patients from these studies, life-time attributable cancer risks (LAR) were estimated using sex-, age-, and organ-specific risk models based on the hypothesis of a linear non-threshold dose-response relationship. For the brain, heart and pelvic cancer studies considered, local absorbed doses in the imaging field were about 100-190 mGy (total CTDI(vol), 200 mGy), 15-30 mGy (16 mGy) and 80-270 mGy (140 mGy), respectively. According to a recent publication of the International Commission on Radiological Protection (ICRP Publication 118, 2012), harmful tissue reactions of the cerebro- and cardiovascular systems as well as of the lenses of the eye become increasingly important at radiation doses of more than 0.5 Gy. The LARs estimated for the investigated cerebral and myocardial DCE-CT scenarios are less than 0.07% for males and 0.1% for females at an age of exposure of 40 years. For the considered tumor location and protocol, the corresponding LARs are more than 6 times as high. Stochastic radiation risks decrease substantially with age and are markedly higher for females than for males. To balance the diagnostic needs and patient protection, DCE-CT studies have to be strictly justified and carefully optimized in due consideration of the various aspects discussed in some detail in this review.

Dose and image quality of cone-beam computed tomography as compared with conventional multislice computed tomography in abdominal imaging.

OBJECTIVES: Recent technical developments have facilitated the application of cone-beam computed tomography (CBCT) for interventional and intraoperative imaging. The aim of this study was to compare the radiation doses and image quality in CBCT with those of conventional multislice spiral computed tomography (MSCT) for abdominal and genitourinary imaging. METHODS: Different CBCT and MSCT protocols for imaging soft tissues and hard-contrast objects at different dose levels were investigated in this study. Local skin and organ doses were measured with thermoluminescent dosimeters placed in an anthropomorphic phantom. Moreover, the contrast-to-noise ratio, the noise-power spectrum, and the high-contrast resolution derived from the modulation transfer function were determined in a phantom with the same absorption properties as those of anthropomorphic phantom. RESULTS: The effective dose of the examined abdominal/genitourinary CBCT protocols ranged between 0.35 mSv and 18.1 mSv. As compared with MSCT, the local skin dose of CBCT examinations could locally reach much higher doses up to 190 mGy. The effective dose necessary to realize the same contrast-to-noise ratio with CBCT and MSCT depended on the MSCT convolution kernel: the MSCT dose was smaller than the corresponding CBCT dose for a soft kernel but higher than that for a hard kernel. The noise-power spectrum of the CBCT images at tube voltages of 85/90 kV(p) is at least half of that of images measured at 103/115 kV(p) at any arbitrarily chosen spatial frequency. Although the pixel size and slice thickness of CBCT were half of those of the MSCT images, high-contrast resolution was inferior to the MSCT images reconstructed with a hard convolution kernel. CONCLUSIONS: As compared with MSCT using a medium-hard convolution kernel, CBCT produces images at medium noise levels and, simultaneously, medium spatial resolution at approximately the same dose. It is well suited for visualizing hard-contrast objects in the abdomen with relatively low image noise and patient dose. For the detection of low-contrast objects at standard tube voltages of approximately 120 kV(p), however, MSCT should be preferred.