A structured FMEA approach to optimizing combinations of plan-specific quality assurance techniques for IMRT and VMAT QA.

BACKGROUND: Many commercial tools are available for plan-specific quality assurance (QA) of radiotherapy plans, with their functionality assessed in isolation. However, multiple QA tools are required to review the full range of potential errors. It is important to assess their effectiveness in combination with each other to look for ways to both streamline the QA process and to make certain that errors of high impact and/or high occurrence are caught before reaching patient treatment. PURPOSE: To develop a structured method to assess the effective risk reduction of combinations of QA methods for IMRT/VMAT treatments. METHODS: First, a structured prospective risk assessment was performed to establish the major failure modes (FMs) of IMRT/VMAT QA, and assign occurrence (O), severity (S), and baseline detectability (BD) rankings to them. The baseline assumed that chart checks and linear accelerator QA was performed, but no plan-specific secondary dose calculation or measurement was done. Second, the detectability of each FM for two secondary dose calculation methods and four plan measurement methods (point-based dose calculation, Monte-Carlo-based dose calculation, 2D fluence-based measurement, 2.5D phantom-based measurement, log file analysis with dose recalculation, and log file analysis combined with MLC QA) was determined. Third, we used a minimum detectability approach in addition to each FM's occurrence and severity to determine the optimal combination of QA methods. We analyzed the cumulative risk priority number of eight combinations of QA methods. The analysis was done on (1) all FMs, (2) FMs with high severity, (3) FMs with high-risk priority numbers (RPN) of O*S*BD, and (4) on FMs with both high severity and high RPN. RESULTS: Our analysis resulted in 54 FMs, including commissioning, planning, data transfer, and linear accelerator failures. 1D secondary dose calculation plus measurement provided a 19%-22% risk reduction from baseline. 1D/3D secondary dose calculation plus log files created a 25%-32% reduction. 3D secondary dose calculation plus measurement resulted in a 27%-34% reduction. 3D secondary dose calculation plus log files with additional machine QA provided the greatest reduction of 31%-42%. CONCLUSION: This novel structured approach to comparing combinations of QA methods will allow us to optimize our procedures, with the goal of detecting all clinically significant FMs. Our results show that log-file QA with 3D dose recalculation and supplemental machine QA provides better risk reduction than measurement-based QA. This work builds evidence to justify reducing or eliminating measurement-based PSQA with an independent 3D dose verification, log-file measurement, and appropriate supplementation of machine QA. The process also highlights FMs that cannot be caught by pre-treatment QA, prompting us to consider future directions for on-treatment QA.

Quantitative Approach to Failure Mode and Effect Analysis for Linear Accelerator Quality Assurance.

PURPOSE: To determine clinic-specific linear accelerator quality assurance (QA) TG-142 test frequencies, to maximize physicist time efficiency and patient treatment quality. METHODS AND MATERIALS: A novel quantitative approach to failure mode and effect analysis is proposed. Nine linear accelerator-years of QA records provided data on failure occurrence rates. The severity of test failure was modeled by introducing corresponding errors into head and neck intensity modulated radiation therapy treatment plans. The relative risk of daily linear accelerator QA was calculated as a function of frequency of test performance. RESULTS: Although the failure severity was greatest for daily imaging QA (imaging vs treatment isocenter and imaging positioning/repositioning), the failure occurrence rate was greatest for output and laser testing. The composite ranking results suggest that performing output and lasers tests daily, imaging versus treatment isocenter and imaging positioning/repositioning tests weekly, and optical distance indicator and jaws versus light field tests biweekly would be acceptable for non-stereotactic radiosurgery/stereotactic body radiation therapy linear accelerators. CONCLUSIONS: Failure mode and effect analysis is a useful tool to determine the relative importance of QA tests from TG-142. Because there are practical time limitations on how many QA tests can be performed, this analysis highlights which tests are the most important and suggests the frequency of testing based on each test's risk priority number.

Diode-based transmission detector for IMRT delivery monitoring: a validation study.

The purpose of this work was to evaluate the potential of a new transmission detector for real-time quality assurance of dynamic-MLC-based radiotherapy. The accuracy of detecting dose variation and static/dynamic MLC position deviations was measured, as well as the impact of the device on the radiation field (surface dose, transmission). Measured dose variations agreed with the known variations within 0.3%. The measurement of static and dynamic MLC position deviations matched the known deviations with high accuracy (0.7-1.2 mm). The absorption of the device was minimal (~ 1%). The increased surface dose was small (1%-9%) but, when added to existing collimator scatter effects could become significant at large field sizes (≥ 30 × 30 cm2). Overall the accuracy and speed of the device show good potential for real-time quality assurance.

6D image guidance for spinal non-invasive stereotactic body radiation therapy: Comparison between ExacTrac X-ray 6D with kilo-voltage cone-beam CT.

PURPOSE: To investigate setup discrepancies measured with ExacTrac X-ray 6 degree-of-freedom (6D) and cone-beam computed tomography (CBCT) for patients under treatments of stereotactic body radiation therapy (SBRT). MATERIALS AND METHODS: In this work, phantom and patient studies were performed. In the phantom studies, an anthropomorphic phantom was placed with pre-defined positions, and imaged with ExacTrac X-ray 6D and CBCT to test the accuracy of the imaging systems. In the patient studies, 16 spinal SBRT patient cases were retrospectively analyzed. The patients were initially positioned in customized immobilization cradles and then aligned with ExacTrac X-ray 6D and CBCT. The setup discrepancies were computed and quantitatively analyzed. RESULTS: This study indicates modest discrepancies between ExacTrac X-ray 6D and CBCT with spinal SBRT. The phantom experiments showed that translational and rotational discrepancies in root-mean-square (RMS) between ExacTrac X-ray 6D and CBCT were, respectively, <1.0mm and <1 degrees . In the retrospective patient studies, translational and rotational discrepancies in RMS between ExacTrac X-ray 6D and CBCT were <2.0mm and <1.5 degrees . CONCLUSIONS: ExacTrac X-ray 6D represents a potential alternative to CBCT; however, pre-caution should be taken when only ExacTrac X-ray 6D is used to guide SBRT with small setup margins.

Daily bone alignment with limited repeat CT correction rivals daily ultrasound alignment for prostate radiotherapy.

PURPOSE: To compare the effectiveness of daily ultrasound (US)- and computed tomography (CT)-guided alignments with an off-line correction protocol using daily bone alignment plus a correction factor for systematic internal prostate displacement (CF(ID)). METHODS AND MATERIALS: Ten prostate cancer patients underwent CT scans three times weekly using an integrated CT-linear accelerator system, followed by alignment using US for daily radiotherapy. Intensity-modulated radiotherapy plans were designed with our current clinical margins. The treatment plan was copied onto the repeat CT images and aligned using several methods: (1) bone alignment plus CF(ID) after three off-line CT scans (bone+3CT), (2) bone alignment plus CF(ID) after six off-line CT scans (bone+6CT), (3) US alignment, and (4) CT alignment. The accuracy of the repeated US and CT measurements to determine the CF(ID) was compared. The target dosimetric effect was quantified. RESULTS: The CF(ID) for internal systematic prostate displacements was more accurately measured with limited repeat CT scans than with US (residual error, 0.0 +/- 0.7 mm vs. 2.0 +/- 3.2 mm). Bone+3CT, bone+6CT, and US provided equivalent prostate and seminal vesicle dose coverage, but bone+3CT and bone+6CT produced more precise daily alignments. Daily CT alignment provided the greatest target dose coverage. CONCLUSION: Daily bone alignment plus CF(ID) for internal systematic prostate displacement provided better daily alignment precision and equivalent dose coverage compared with daily US alignment. The CF(ID) should be based on at least three repeat CT scans, which could be collected before the start of treatment or during the first 3 treatment days. Daily bone alignment plus CF(ID) provides another option for accurate prostate cancer patient positioning.

Parotid gland dose in intensity-modulated radiotherapy for head and neck cancer: is what you plan what you get?

PURPOSE: To quantify the differences between planned and delivered parotid gland and target doses, and to assess the benefits of daily bone alignment for head and neck cancer patients treated with intensity-modulated radiotherapy (IMRT). METHODS AND MATERIALS: Eleven head and neck cancer patients received two CT scans per week with an in-room CT scanner over the course of their radiotherapy. The clinical IMRT plans, designed with 3-mm to 4-mm planning margins, were recalculated on the repeat CT images. The plans were aligned using the actual treatment isocenter marked with radiopaque markers (BB) and bone alignment to the cervical vertebrae to simulate image-guided setup. In-house deformable image registration software was used to map daily dose distributions to the original treatment plan and to calculate a cumulative delivered dose distribution for each patient. RESULTS: Using conventional BB alignment led to increases in the parotid gland mean dose above the planned dose by 5 to 7 Gy in 45% of the patients (median, 3.0 Gy ipsilateral, p = 0.026; median, 1.0 Gy contralateral, p = 0.016). Use of bone alignment led to reductions relative to BB alignment in 91% of patients (median, 2 Gy; range, 0.3-8.3 Gy; 15 of 22 parotids improved). However, the parotid dose from bone alignment was still greater than planned (median, 1.0 Gy, p = 0.007). Neither approach affected tumor dose coverage. CONCLUSIONS: With conventional BB alignment, the parotid gland mean dose was significantly increased above the planned mean dose. Using daily bone alignment reduced the parotid dose compared with BB alignment in almost all patients. A 3- to 4-mm planning margin was adequate for tumor dose coverage.

Is a 3-mm intrafractional margin sufficient for daily image-guided intensity-modulated radiation therapy of prostate cancer?

PURPOSE: To determine whether a 3-mm isotropic target margin adequately covers the prostate and seminal vesicles (SVs) during administration of an intensity-modulated radiation therapy (IMRT) treatment fraction, assuming that daily image-guided setup is performed just before each fraction. MATERIALS AND METHODS: In-room computed tomographic (CT) scans were acquired immediately before and after a daily treatment fraction in 46 patients with prostate cancer. An eight-field IMRT plan was designed using the pre-fraction CT with a 3-mm margin and subsequently recalculated on the post-fraction CT. For convenience of comparison, dose plans were scaled to full course of treatment (75.6 Gy). Dose coverage was assessed on the post-treatment CT image set. RESULTS: During one treatment fraction (21.4+/-5.5 min), there were reductions in the volumes of the prostate and SVs receiving the prescribed dose (median reduction 0.1% and 1.0%, respectively, p<0.001) and in the minimum dose to 0.1 cm(3) of their volumes (median reduction 0.5 and 1.5 Gy, p<0.001). Of the 46 patients, three patients' prostates and eight patients' SVs did not maintain dose coverage above 70 Gy. Rectal filling correlated with decreased percentage-volume of SV receiving 75.6, 70, and 60 Gy (p<0.02). CONCLUSIONS: The 3-mm intrafractional margin was adequate for prostate dose coverage. However, a significant subset of patients lost SV dose coverage. The rectal volume change significantly affected SV dose coverage. For advanced-stage prostate cancers, we recommend to use larger margins or improve organ immobilization (such as with a rectal balloon) to ensure SV coverage.

The effect of dental artifacts, contrast media, and experience on interobserver contouring variations in head and neck anatomy.

OBJECTIVES: To investigate interobserver variability in the delineation of head-and-neck (H&N) anatomic structures on CT images, including the effects of image artifacts and observer experience. METHODS: Nine observers (7 radiation oncologists, 1 surgeon, and 1 physician assistant) with varying levels of H&N delineation experience independently contoured H&N gross tumor volumes and critical structures on radiation therapy treatment planning CT images alongside reference diagnostic CT images for 4 patients with oropharynx cancer. Image artifacts from dental fillings partially obstructed 3 images. Differences in the structure volumes, center-of-volume positions, and boundary positions (1 SD) were measured. In-house software created three-dimensional overlap distributions, including all observers. The effects of dental artifacts and observer experience on contouring precision were investigated, and the need for contrast media was assessed. RESULTS: In the absence of artifacts, all 9 participants achieved reasonable precision (1 SD < or =3 mm all boundaries). The structures obscured by dental image artifacts had larger variations when measured by the 3 metrics (1 SD = 8 mm cranial/caudal boundary). Experience improved the interobserver consistency of contouring for structures obscured by artifacts (1 SD = 2 mm cranial/caudal boundary). CONCLUSIONS: Interobserver contouring variability for anatomic H&N structures, specifically oropharyngeal gross tumor volumes and parotid glands, was acceptable in the absence of artifacts. Dental artifacts increased the contouring variability, but experienced participants achieved reasonable precision even with artifacts present. With a staging contrast CT image as a reference, delineation on a noncontrast treatment planning CT image can achieve acceptable precision.

Dosimetric comparison of four target alignment methods for prostate cancer radiotherapy.

PURPOSE: The aim of this study was to compare the dosimetric consequences of 4 treatment delivery techniques for prostate cancer patients treated with intensity-modulated radiotherapy (IMRT). METHODS AND MATERIALS: During an 8-week course of radiotherapy, 10 patients underwent computed tomography (CT) scans 3 times per week (243 total) before daily treatment with a CT-linear accelerator. Treatment delivery was simulated by realigning a fixed-margin treatment plan on each CT scan and calculating doses. The alignment methods were those based on the following: skin marks, bony registration, ultrasonography (US), and in-room CT. For the last two methods, prostate was the alignment target. The dosimetric effects of these alignment methods on the prostate, seminal vesicles, rectum, and bladder were compared. The average daily minimum dose to 0.1 cm3 was used as the metric for target coverage. RESULTS: Skin and bone alignments provided acceptable prostate coverage for only 70% of patients, US alignment for 90%, and CT alignment for 100%. CT-based alignment of the prostate provided seminal vesicle (SV) coverage of > or = 69 Gy for all patients; US and bone alignments provided SV coverage of > or = 60 Gy. This SV coverage may be acceptable for early-stage cancer (equivalent SV dose = 55.8 Gy at 1.8 Gy per fraction), but unacceptable for late-stage cancer (SV dose = 75.6 Gy). At 75.6 Gy, the acceptable rate for SV coverage was 40% for skin and bone alignments, 70% for US, and 80% for CT. CONCLUSIONS: Direct target alignment methods (US and CT) provided better target coverage. CT-guided alignment provided the best and most consistent dosimetric coverage. A larger planning target volume margin is needed for SV coverage when the alignment target is the prostate.

Reducing radiation exposure from survey CT scans.

OBJECTIVE: The purpose of this study was to focus attention on the technique factors commonly used in survey CT scans (e.g., scout, topogram, or pilot scans) to measure the radiation exposure from typical survey CT scans, to compare their exposure to that of typical chest radiographs, and to explore methods for radiation exposure reduction. MATERIALS AND METHODS: The default survey CT scans on 21 CT scanners, representing three different vendors and 11 different models, were investigated. Exposure measurements were obtained with an ion chamber at isocenter and adjusted to be consistent with standard chest radiographic exposure measurement methods (single posterior-anterior projection). These entrance exposures were compared with those of typical chest radiographs, for which the mean for average-sized adults is 16 mR (4.1 x 10(-6) C/kg). RESULTS: The entrance exposures of the default survey CT scans ranged from 3.2 to 74.7 mR (0.8 to 19.3 x 10(-6) C/kg), which is equivalent to approximately 0.2 to 4.7 chest radiographs. By changing the default scan parameters from 120 kVp to 80 kVp and the tube position from 0 degrees (tube above table) to 180 degrees (tube below table), the entrance exposure for the survey CT scan was reduced to less than that of one chest radiograph for all CT scanners. CONCLUSION: For institutions at which the interpreting radiologists do not rely heavily on the appearance of the survey CT image, we recommend adjusting the technique parameters (kilovoltage and X-ray tube position) to decrease radiation exposure, especially for vulnerable patient populations such as children and young women.

Quantification of volumetric and geometric changes occurring during fractionated radiotherapy for head-and-neck cancer using an integrated CT/linear accelerator system.

PURPOSE: Many patients receiving fractionated radiotherapy (RT) for head-and-neck cancer have marked anatomic changes during their course of treatment, including shrinking of the primary tumor or nodal masses, resolving postoperative changes/edema, and changes in overall body habitus/weight loss. We conducted a pilot study to quantify the magnitude of these anatomic changes with systematic CT imaging. METHODS AND MATERIALS: Fourteen assessable patients were enrolled in this pilot study. Eligible patients had to have a pathologic diagnosis of head-and-neck cancer, be treated with definitive external beam RT, and had have gross primary and/or cervical nodal disease measuring at least 4 cm in maximal diameter. All patients were treated using a new commercial integrated CT-linear accelerator system (EXaCT) that allows CT imaging at the daily RT sessions while the patient remains immobilized in the treatment position. CT scans were acquired three times weekly during the entire course of RT, and both gross tumor volumes (GTVs: primary tumor and involved lymph nodes) and normal tissues (parotid glands, spinal canal, mandible, and external contour) were manually contoured on every axial slice. Volumetric and positional changes relative to a central bony reference (the center of mass of the C2 vertebral body) were determined for each structure. RESULTS: Gross tumor volumes decreased throughout the course of fractionated RT, at a median rate of 0.2 cm(3) per treatment day (range, 0.01-1.95 cm(3)/d). In terms of the percentage of the initial volume, the GTVs decreased at a median rate of 1.8%/treatment day (range, 0.2-3.1%/d). On the last day of treatment, this corresponded to a median total relative loss of 69.5% of the initial GTV (range, 9.9-91.9%). In addition, the center of the mass of shrinking tumors changed position with time, indicating that GTV loss was frequently asymmetric. At treatment completion, the median center of the mass displacement (after corrections for daily setup variation) was 3.3 mm (range, 0-17.3 mm). Parotid glands also decreased in volume (median, 0.19 cm(3)/d range, 0.04-0.84 cm(3)/d), and generally shifted medially (median, 3.1 mm; range, 0-9.9 mm) with time. This medial displacement of the parotid glands correlated highly with the weight loss that occurred during treatment. CONCLUSION: Measurable anatomic changes occurred throughout fractionated external beam RT for head-and-neck cancers. These changes in the external contour, shape, and location of the target and critical structures appeared to be significant during the second half of treatment (after 3-4 weeks of treatment) and could have potential dosimetric impact when highly conformal treatment techniques are used. These data may, therefore, be useful in the development of an adaptive RT scheme (periodic adjustment of the conformal treatment plan) that takes into account such treatment-related anatomic changes. In theory, such a strategy would maximize the therapeutic ratio of RT.

Strategies for formulating appropriate MDCT techniques when imaging the chest, abdomen, and pelvis in pediatric patients.

OBJECTIVE: Our aim was to formulate appropriate MDCT chest and abdominopelvic CT scan protocols for pediatric patients. MATERIALS AND METHODS: Surface radiation dose measurements from a set of anthropomorphic phantoms (nominal 1 year old, 5 year old, and 10 year old) and an adult phantom were compared with standard CT dose index measurements. Image-noise values on axial 5-mm-thick anthropomorphic phantom images were obtained as a measure of image quality. RESULTS: Peripheral CT dose index values obtained with the standard 16-cm acrylic phantom were within approximately 10% of the CT surface dose measurements for the pediatric anthropomorphic phantoms for both chest and abdominopelvic scan protocols. The noise value for the adult phantom image acquired using a typical clinical CT technique was identified, and targeting this level of noise for pediatric CT examinations resulted in a decrease in dose of 60-90%. Initially, 80 kVp was selected for use with very small children; however, beam-hardening artifacts were severe enough to cause us to abandon this option. Current pediatric protocols at M. D. Anderson Cancer Center rely on 100- and 120-kVp settings. The display field-of-view parameter can be used as a surrogate for patient size to develop clinical pediatric CT protocol charts. CONCLUSION: CT dose index measurements obtained using the 16-cm standard acrylic phantom are sufficiently accurate for estimating chest and abdominopelvic CT entrance exposures for pediatric patients of the same approximate size as the anthropomorphic phantoms used in this study. Image-noise measurements can be used to adjust chest and abdominopelvic CT techniques for pediatric populations, resulting in a decrease in measured entrance dose by 60-90%.

The delivery of IMRT with a single physical modulator for multiple fields: a feasibility study for paranasal sinus cancer.

PURPOSE: This study describes a new intensity-modulated radiation therapy (IMRT) delivery method that utilizes a single modulator to deliver multiple fields ("multifield modulator"). This technique reduces the treatment time and manufacturing costs typically associated with modulator-IMRT. Technical feasibility was evaluated for treating paranasal sinus cancers. METHODS AND MATERIALS: Technical feasibility was measured by three criteria: The dose distributions of the multifield modulator-IMRT plans should offer improvements over those produced by 3D conformal plans and be equivalent to those of step-and-shoot multileaf collimator (MLC) IMRT plans, the manufactured modulators should meet quality assurance specifications, and the effort required to use this technology should not substantially exceed the effort required for current IMRT practice. Seven paranasal cancer cases were examined. The Wilcoxon signed rank test was used for statistical analysis. RESULTS: Multifield modulator-IMRT plans can improve target coverage while reducing critical structure doses compared to 3D conformal plans. Multifield modulator-IMRT plans are at least equivalent to the corresponding step-and-shoot MLC-IMRT plans. Multifield modulators can be constructed to meet design specifications in quality assurance tests. The time required for manufacturing, quality assurance, and treatment delivery using multifield modulators was measured and found to be only slightly greater than that for current IMRT treatment methods. CONCLUSIONS: IMRT treatments using multifield modulators for paranasal sinus tumors are feasible. Clinics may find it worthwhile to commit the minimal extra time for quality assurance and treatment to benefit from the improved dose distribution and lack of interplay between MLC leaf motion and internal target motion.