A patient-centric approach to quality control and dosimetry in CT including CBCT.

One measurement and an algebraic formula are used to calculate the incident air kerma (Ka,i) at the skin after any CT examination, including cone-beam CT (CBCT) and multi-slice CT (MSCT). Empty scans were performed with X-ray CBCT systems (dental, C-arm and linac guidance scanners) as well as two MSCT scanners. The accumulated Ka,i at the flat panel (in CBCT) or the maximum incident air kerma at the isocentre (in MSCT) were measured using a solid-state probe. The average Ka,i(skin), at the skin of a hypothetical patient, was calculated using the proposed formula. Additional measurements of dose at the isocentre (DFOV) and kerma-area product (KAP), as well as Ka,i(skin) from thermoluminiscence dosimeters (TLDs) and size-specific dose estimates are presented for comparison. The Ka,i(skin) for the standard head size in the dental scanner, the C-arm (high dose head protocol) and the linac (head protocol) were respectively 3.33 ±â€¯0.19 mGy, 15.15 ±â€¯0.76 mGy and 3.23 ±â€¯0.16 mGy. For the first MSCT, the calculated Ka,i(skin) was 13.1 ±â€¯0.7 mGy and the TLDs provided a Ka,i(skin) between 10.3 ±â€¯1.1 mGy and 13.8 ±â€¯1.4 mGy. Estimation of patient air kerma in tomography with an uncertainty below 7% is thus feasible using an empty scan and conventional measurement tools. The provided equations and website can be applied to a standard size for the sake of quality control or to several sizes for the definition of diagnostic reference levels (DRLs). The obtained incident air kerma can be directly compared to the Ka,i from other X-ray modalities as recommended by ICRU and IAEA.

Validation of thin layer and high performance thin layer chromatographic methods.

Analytical validation is a key requirement to asses and to prove a method's reliability and suitability for an intended use. Planar chromatographic procedures are used in different applications ranging from simple screening tests to sophisticated instrumental quantitative assays of analytes in complex matrices. This paper intends to give guidance on how to adopt international accepted formal requirements and guidelines for validation of these different TLC/HPTLC procedures. In addition, some selected parameters for robustness testing and for on going quality assurance of analytical performance based on control charts are reported.

Impurity profiling of pharmaceuticals by thin-layer chromatography.

Although there is a tendency in current pharmacopoeias for favouring HPLC, thin-layer chromatography (TLC) is still a very popular and frequently used analytical method in the pharmaceutical industry. This paper highlights the possibilities of this method in the different areas of pharmaceutical analysis like in-process and intermediate control, illustrated by impurity testing of active ingredients and final products, as well as its application in pharmaceutical research and development, based on some examples reported mainly in the last five years.

Cascaded systems analysis in conventional X-ray CT: a new, objective approach.

The objective of this study is to separately analyse the effects of detection and image reconstruction on computed tomography (CT) performance to characterise standard and new CT systems. The focus here was on the determination of quantifiable parameters, such as the modulation transfer function, noise power spectrum and quantum efficiency of the detector and the entire system, considering the CT image and the raw data set. Because of the conversion of raw data and image data to the absolute scale of the photon number, a quantitative comparison between the quality parameters of both data sets is possible in this approach. The effort of the proposed method using simple, standardised test phantoms is comparable with the effort in the quality control in classical projection radiography. For the first time, the quantum efficiency of a CT detector and the entire system that is used in the daily clinical practice could be determined. This system reached a quantum efficiency up to 12 %.

Validation and quality assurance of planar chromatographic procedures in pharmaceutical analysis.

Within the process of the International Conference on Harmonization (ICH), 2 guidelines were released containing a standardized terminology, a verified model of requirements for the validation of analytical procedures, and some guidance in the practical aspects of conducting validation studies in pharmaceutical analysis. For planar chromatographic procedures, which may be used at different levels either in qualitative identity testing, assays, semiquantitative limit tests, or quantitative determination of impurities, this paper tries to transfer these formal requirements into practical approaches for validation. Basic acceptance criteria for evaluation of validation experiments based on practical experience are proposed. In addition, selected parameters for robustness testing of given procedures and quality assurance of quantitative planar chromatographic testing by control charts is described.

[MRI study of left ventricular function in patients with coronary disease and myocardial dysfunction before and after coronary revascularization]. / MR-tomographische Untersuchung der linksventrikulären Funktion bei Patienten mit koronarer Herzerkrankung und myokardialer Dysfunktion vor und nach koronarchirurgischer Revaskularisation.

PURPOSE: To evaluate left ventricular (LV) myocardial function in ten patients with coronary artery disease (CAD) preoperatively and 6 months after coronary bypass grafting (CABG) by cardiac MRI. MATERIAL AND METHODS: Ten patients (mean 65.2 +/- 5.9 years) with angiographically proven CAD and an indication for elective CABG underwent prospective evaluation of global LV function and regional wall motion by Cine-MRI at rest using a multiphase FLASH-2D sequence following regions of interest (ROI)-defined diagnostics of regional myocardial wall motion by means of levocardiography. Within the ROIs a total of 613 LV myocardial segments were analyzed preceding and following surgical revascularization. Results were compared with the data of 10 healthy volunteers. RESULTS: Preoperatively, patients showed reduced stroke volume and ejection fraction compared with volunteers (p < 0.01). Enddiastolic wall thickness (EDWT) and systolic wall thickening (SWT) were significantly lower in the patients (p < 0.01). Based on preoperative levocardiography ROI-defined myocardial segments showed a significantly lower preoperative EDWT in areas with wall motion abnormalities (7.4 +/- 2.5 mm; p < 0.01) than in normal myocardium (9.2 +/- 2.1 mm). Ejection fraction (p < 0.05), endsystolic wall thickness, and SWT (p < 0.01) improved significantly after bypass surgery. On ROI-defined analysis myocardial segments with impaired preoperative wall motion (n = 243) showed a significant increase of EDWT, ESWT and SWT (p < 0.01). CONCLUSION: In patients with CAD, cardiac MRI enables the non-invasive determination of postinfarctional LV remodeling with an increased EDWT of myocardial segments with normal regional wall motion and of the improvement in global and regional myocardial function following coronary bypass surgery.

System performance and variability of chromatographic techniques used in pharmaceutical quality control.

Data representing the routine performance of different chromatographic equipment systems used in pharmaceutical quality control are presented. These performance data allow one to predict long-term relative uncertainties and confidence intervals for different chromatographic procedures and techniques. From the variability that is to be expected, it is apparent that many chromatographic procedures run as routine applications in the pharmaceutical industry are unlikely to be capable of controlling the tight specification limits like those usually demanded for bulk drug substances (active pharmaceutical ingredients), the European 95-105% expectation for finished drugs, or to be used in stability studies.

Selenium-based digital radiography in the detection of bone lesions: preliminary experience with experimentally created defects.

PURPOSE: To compare the diagnostic performance of selenium-based digital radiography with that of conventional screen-film radiography and storage phosphor radiography for the detection of bone lesions simulating osteolyses. MATERIALS AND METHODS: Artificial osseous lesions 1.0-3.0 mm in diameter were created in 80 of 160 predefined regions in 16 porcine femoral specimens. Specimens were enclosed in containers filled with paraffin to ensure accurate repositioning and to obtain an absorption condition comparable to that of a human extremity. Imaging was performed with a selenium-based digital radiography system, a conventional screen-film system, and a storage phosphor radiography system with an exposure identical to that used during clinical imaging. The presence of a lesion was assessed with a five-point confidence scale. Receiver operating characteristic (ROC) analysis was performed for a total of 1,440 observations (480 per modality), and diagnostic performance was estimated with the area under the ROC curve (A(z)). Differences in diagnostic performance were assessed with the paired Student t test. RESULTS: ROC analysis results showed A(z) values of 0.656 for selenium-based digital radiography, 0.679 for storage phosphor radiography, and 0.680 for conventional screen-film radiography. Differences between the three modalities were not significant (P =.60-.93). CONCLUSION: Image quality with selenium-based digital radiography was comparable to that with conventional screen-film radiography and storage phosphor radiography.

Optimized activation of the primary sensorimotor cortex for clinical functional MR imaging.

BACKGROUND AND PURPOSE: One application of functional MR imaging is to identify the primary sensorimotor cortex (M1 and S1) around the central sulcus before brain surgery. However, it has been shown that undesirable coactivation of nonprimary motor areas, such as the supplementary motor area and the premotor area, can interfere with the identification of the primary motor cortex, especially in patients with distorted anatomic landmarks. We therefore sought to design a simple functional MR imaging paradigm for selective activation of the primary sensorimotor cortex. METHODS: Different paradigms using finger tapping for motor activation were examined and compared with respect to the distribution of activated voxels in primary and nonprimary cortical areas. Studies were conducted in 14 healthy volunteers using a blood oxygen level-dependent multislice echo-planar imaging sequence. RESULTS: The most selective activation of the primary sensorimotor cortex was obtained with a paradigm combining right-sided finger tapping as the activation condition with left-sided finger tapping as the control condition. Analysis of the signal time course of primary and nonprimary areas revealed that the highly selective primary motor activation was due to it being restricted to contralateral finger movements, as opposed to the nonprimary motor areas, which were activated by ipsilateral, contralateral, and bilateral finger movements alike. CONCLUSION: When performing functional MR imaging to determine the location of the primary sensorimotor cortex, one should compare unilateral voluntary movements as the activation condition with contralateral movements as the control condition to accentuate activation of the primary motor area and to suppress undesirable coactivation of nonprimary motor areas.

[The texture-analysis of high-resolution computed tomograms as an additional procedure in osteoporosis diagnosis: in-vitro studies on vertebral segments]. / Strukturanalyse hochauflösender Computertomogramme als ergänzendes Verfahren in der Osteoporosediagnostik: in-vitro-Untersuchungen an Wirbelsäulensegmenten.

PURPOSE: The purpose of this study was to perform texture analysis of high-resolution CT images obtained from human vertebral specimens and to correlate these parameters with the biomechanical stability of the specimens. In addition, structure data were compared with bone mineral density (BMD) assessed by quantitative CT (QCT). MATERIAL AND METHODS: High-resolution CT images and standard QCT sections were obtained in 36 vertebral motion segments, each consisting of two vertebrae with intact ligaments and intervertebral disc. The trabecular structure in the CT images was assessed using three texture analysis techniques: Trabecular threshold area ratio (TTAR), fractal dimension without thresholding (OTS) and fractal dimension with thresholding (ITS). Finally, the maximum compressive strength (MCS) was determined using a biomechanical testing device. RESULTS: A correlation of r = 0.76 (p < 0.01) was obtained for TTAR versus MCS, of r = 0.83 (p < 0.01) for ITS versus MCS, and of r = 0.35 (p > 0.01) for OTS versus MCS, while r = 0.76 (p < 0.01) was found for BMD versus MCS. Best results were obtained by combining structure measures and BMD (r = 0.85, p < 0.01). CONCLUSIONS: This in vitro study showed a significant correlation between structure measures and biomechanical strength, which was comparable to BMD and strength. However, best correlations were obtained by combining both measures. Using both BMD and structure measures therefore may improve the prediction of biomechanically determined bone strength.

Clinical applications of functional MRI at 1.0 T: motor and language studies in healthy subjects and patients.

In this article we describe clinical applications of functional MRI (fMRI) at 1.0 T. All experiments were performed on a commercially available 1.0-T system (Magnetom Impact Expert, Siemens AG, Erlangen, Germany) using a blood oxygen level-dependent (BOLD)-sensitive multi-slice EPI technique (TE 66 ms, 4 mm slice thickness, 210 mm field of view, 64 x 64 acquisition matrix). Different paradigms for localization of the motor cortex and for language lateralization were tested in healthy subjects and patients. Methodological considerations concerning the development of the paradigms are also described. In all healthy subjects, motor activation elicited BOLD signal changes in the sensorimotor cortex, permitting identification of primary motor and sensory cortical areas. Furthermore, focal activation of different cortical areas by a language task was possible in 6 of 10 subjects. Nineteen motor studies were performed in 18 patients with supratentorial lesions, in most cases prior to neurosurgical procedures. In 14 studies, fMRI results demonstrated the localization of the motor hand areas relative to the lesion. The results proved valuable for preoperative planning and contributed to therapeutical decisions. We conclude that functional MRI for clinically relevant applications, such as localization of motor and language function, is feasible even at a field strength of 1.0 T without dedicated equipment.

Automatic bone segmentation technique for CT angiographic studies.

PURPOSE: The purpose of this work was to develop and evaluate an automatic bone segmentation technique for CT angiographic studies. METHOD: An automatic bone segmentation scheme was developed and applied to 40 CT examinations. The results of the segmentation were evaluated subjectively by two radiologists. RESULTS: The bone segmentation was, on average, rated between excellent and good. Automatic segmentation required approximately 25 s/case. CONCLUSION: With this high quality technique, bone can be segmented easily and accurately and subsequently can be removed from CT data sets for further 3D visualization and analysis of various organs.

[Medical cooperation on the internet]. / Medizinische Zusammenarbeit im Netz.

Post-1999, the economically united EEC will pose new challenges to European business, industry and citizen. It is a key objective that in the domain of European "infostructure" these problems are challenged and overcome, and that "advanced communications technologies and services" (ACTS) become the cement which binds the Community together. Within ACTS, 130 different projects are building new services. The consortium Emerald develops a telemedicine platform, setting up teleworking with teleconference, computer supported co-operative work (cscw, joint editing), demonstration and teleteaching for radiology, cardiology, nuclear medicine and radio surgery working environments.