Improving radiotherapy quality assurance in clinical trials: assessment of target volume delineation of the pre-accrual benchmark case.
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ABSTRACT:
SUBMITTER: Gwynne S
PROVIDER: S-EPMC3635785 | biostudies-other | 2013 Apr
REPOSITORIES: biostudies-other
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Project description:We aimed to evaluate the inter-clinician variability in the clinical target volume (CTV) for postoperative radiotherapy (PORT) for biliary tract cancer (BTC) including extrahepatic bile duct cancer (EBDC) and gallbladder cancer (GBC). Nine experienced radiation oncologists delineated PORT CTVs for distal EBDC (pT2N1), proximal EBDC (pT2bN1) and GBC (pT2bN1) patients. The expectation maximization algorithm for Simultaneous Truth and Performance Level Estimation (STAPLE) was used to quantify expert agreements. We generated volumes with a confidence level of 80% to compare the maximum distance to each CTV in six directions. The degree of agreement was moderate; overall kappa values were 0.573 for distal EBDC, 0.513 for proximal EBDC, and 0.511 for GBC. In the distal EBDC, a larger variation was noted in the right, post, and inferior direction. In the proximal EBDC, all borders except the right and left direction showed a larger variation. In the GBC, a larger variation was found in the anterior, posterior, and inferior direction. The posterior and inferior borders were the common area having discrepancies, associated with the insufficient coverage of the paraaortic node. A consensus guideline is needed to reduce inter-clinician variability in the CTVs and adequate coverage of regional lymph node area.
| S-EPMC9436049 | biostudies-literature
Project description:PurposeIn the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design.Methods and materialsParticipants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA.ResultsFour recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States.ConclusionRadiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.
| S-EPMC3361528 | biostudies-literature
Project description:Background and purposeExisting methods for quality assurance of the radiotherapy auto-segmentations focus on the correlation between the average model entropy and the Dice Similarity Coefficient (DSC) only. We identified a metric directly derived from the output of the network and correlated it with clinically relevant metrics for contour accuracy.Materials and methodsMagnetic Resonance Imaging auto-segmentations were available for the gross tumor volume for cervical cancer brachytherapy (106 segmentations) and for the clinical target volume for rectal cancer external-beam radiotherapy (77 segmentations). The nnU-Net's output before binarization was taken as a score map. We defined a metric as the mean of the voxels in the score map above a threshold (λ). Comparisons were made with the mean and standard deviation over the score map and with the mean over the entropy map. The DSC, the 95th Hausdorff distance, the mean surface distance (MSD) and the surface DSC were computed for segmentation quality. Correlations between the studied metrics and model quality were assessed with the Pearson correlation coefficient (r). The area under the curve (AUC) was determined for detecting segmentations that require reviewing.ResultsFor both tasks, our metric (λ = 0.30) correlated more strongly with the segmentation quality than the mean over the entropy map (for surface DSC, r > 0.65 vs. r < 0.60). The AUC was above 0.84 for detecting MSD values above 2 mm.ConclusionsOur metric correlated strongly with clinically relevant segmentation metrics and detected segmentations that required reviewing, indicating its potential for automatic quality assurance of radiotherapy target auto-segmentations.
| S-EPMC10587515 | biostudies-literature
Project description:With the high locoregional relapse rate and the improvement of radiation technology, postoperative radiotherapy (PORT) has been widely used in the treatment of completely resected stage IIIA-pN2 non-small-cell lung cancer (NSCLC). However, there is still no definitive consensus on clinical target volume for the pN2 subgroup. This review will discuss how to delineate the clinical target volume (CTV) for pN2 subgroups of IIIA-N2 NSCLC based on the published literature and to investigate the optimal PORT CTV in this cohort of patients. Besides overall survival (OS), locoregional recurrence (LR), and radiotherapy-related toxicity of this subset of the population in the modern PORT era, selection of proper patients will also be considered in this review. In summary, it is appropriate to include involved lymph node stations and uninvolved stations at high risk in PORT CTV for patients with pN2 disease when PORT is administered. PORT can reduce LR and has the potential to improve OS. In the current era of modern radiation technology, PORT can be administered safely with well-tolerated toxicity. Clinicopathological characteristics may be helpful in selecting proper candidates for PORT.
| S-EPMC4767117 | biostudies-literature
Project description:The purpose of this study was the prospective comparison of objective and subjective effects of target volume region of interest (ROI) delineation using mouse-keyboard and pen-tablet user input devices (UIDs). The study was designed as a prospective test/retest sequence, with Wilcoxon signed rank test for matched-pair comparison. Twenty-one physician-observers contoured target volume ROIs on four standardized cases (representative of brain, prostate, lung, and head and neck malignancies) twice: once using QWERTY keyboard/scroll-wheel mouse UID and once with pen-tablet UID (DTX2100, Wacom Technology Corporation, Vancouver, WA, USA). Active task time, ROI manipulation task data, and subjective survey data were collected. One hundred twenty-nine target volume ROI sets were collected, with 62 paired pen-tablet/mouse-keyboard sessions. Active contouring time was reduced using the pen-tablet UID, with mean ± SD active contouring time of 26?±?23 min, compared with 32?±?25 with the mouse (p???0.01). Subjective estimation of time spent was also reduced from 31?±?26 with mouse to 27?±?22 min with the pen (p?=?0.02). Task analysis showed ROI correction task reduction (p?=?0.045) and decreased panning and scrolling tasks (p?<?0.01) with the pen-tablet; drawing, window/level changes, and zoom commands were unchanged (p?=?n.s.) Volumetric analysis demonstrated no detectable differences in ROI volume nor intra- or inter-observer volumetric coverage. Fifty-two of 62 (84%) users preferred the tablet for each contouring task; 5 of 62 (8%) denoted no preference, and 5 of 62 (8%) chose the mouse interface. The pen-tablet UID reduced active contouring time and reduced correction of ROIs, without substantially altering ROI volume/coverage.
| S-EPMC3180541 | biostudies-literature
Project description:Four-dimensional computed tomography (4D-CT) is commonly used to account for respiratory motion of target volumes in radiotherapy to the thorax. From the 4D-CT acquisition, a maximum-intensity projection (MIP) image set can be created and used to help define the tumor motion envelope or the internal gross tumor volume (iGTV). The purpose of this study was to quantify the differences in automatically contoured target volumes for usage in the delivery of stereotactic body radiation therapy using MIP data sets generated from one of the four methods: (1) 4D-CT phase-binned (PB) based on retrospective phase calculations, (2) 4D-CT phase-corrected phase-binned (PC-PB) based on motion extrema, (3) 4D-CT amplitude-binned (AB), and (4) cine CT built from all available images.MIP image data sets using each of the four methods were generated for a cohort of 28 patients who had prior thoracic 4D-CT scans that exhibited lung tumor motion of at least 1 cm. Each MIP image set was automatically contoured on commercial radiation treatment planning system. Margins were added to the iGTV to observe differences in the final simulated planning target volumes (PTVs).For all patients, the iGTV measured on the MIP generated from the entire cine CT data set (iGTVcine) was the largest. Expressed as a percentage of iGTVcine, 4D-CT iGTV (all sorting methods) ranged from 83.8% to 99.1%, representing differences in the absolute volume ranging from 0.02 to 4.20 cm3; the largest average and range of 4D-CT iGTV measurements was from the PC-PB data set. Expressed as a percentage of PTVcine (expansions applied to iGTVeine), the 4D-CT PTV ranged from 87.6% to 99.6%, representing differences in the absolute volume ranging from 0.08 to 7.42 cm3. Regions of the measured respiratory waveform corresponding to a rapid change of phase or amplitude showed an increased susceptibility to the selection of identical images for adjacent bins. Duplicate image selection was most common in the AB implementation, followed by the PC-PB method. The authors also found that the image associated with the minimum amplitude measurement did not always correlate with the image that showed maximum tumor motion extent.The authors identified cases in which the MIP generated from a 4D-CT sorting process under-represented the iGTV by more than 10% or up to 4.2 cm3 when compared to the iGTVcine. They suggest utilization of a MIP generated from the full cine CT data set to ensure maximum inclusive tumor extent.
| S-EPMC3810265 | biostudies-other
Project description:PurposeTo investigate the interobserver variability (IOV) in target volume delineation of definitive radiotherapy for thoracic esophageal cancer (TEC) among cancer centers in China, and ultimately improve contouring consistency as much as possible to lay the foundation for multi-center prospective studies.MethodsSixteen cancer centers throughout China participated in this study. In Phase 1, three suitable cases with upper, middle, and lower TEC were chosen, and participants were asked to contour a group of gross tumor volume (GTV-T), nodal gross tumor volume (GTV-N) and clinical target volume (CTV) for each case based on their routine experience. In Phase 2, the same clinicians were instructed to follow a contouring protocol to re-contour another group of target volume. The variation of the target volume was analyzed and quantified using dice similarity coefficient (DSC).ResultsSixteen clinicians provided routine volumes, whereas ten provided both routine and protocol volumes for each case. The IOV of routine GTV-N was the most striking in all cases, with the smallest DSC of 0.37 (95% CI 0.32-0.42), followed by CTV, whereas GTV-T showed high consistency. After following the protocol, the smallest DSC of GTV-N was improved to 0.64 (95% CI 0.45-0.83, P = 0.005) but the DSC of GTV-T and CTV remained constant in most cases.ConclusionVariability in target volume delineation was observed, but it could be significantly reduced and controlled using mandatory interventions.
| S-EPMC8188796 | biostudies-literature
Project description:The impact of radiotherapy (RT) quality assurance (QA) has been demonstrated by numerous studies and is particularly important for head and neck cancer (HNC) treatment due to the complexity of RT target volumes in this region and the multiple adjacent organs at risk. The RT planning process includes many critical steps including interpretation of diagnostic imaging, image fusion, target volume delineation (tumor, lymph nodes, and organs at risk), and planning. Each step has become highly complex, and precise and rigorous QA throughout the planning process is essential. The ultimate aim is to precisely deliver radiation dose to the target, maximizing the tumor dose and minimizing the dose to surrounding organs at risk, in order to improve the therapeutic index. It is imperative that RT QA programs should systematically control all aspects of the RT planning pathway and include regular end-to-end tests and external audits. However, comprehensive QA should not be limited to RT and should, where possible, also be implemented for surgery, systemic therapy, pathology, as well as other aspects involved in the interdisciplinary treatment of HNC.
| S-EPMC7081058 | biostudies-literature
Project description:SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres.A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins.36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm3; and PTV volumes 221.9-513.3 cm3. For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial.The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol.The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .
| S-EPMC5688711 | biostudies-literature
Project description:BackgroundStereotactic body radiotherapy (SBRT) has emerged recently as a novel therapeutic alternative for patients with ventricular tachycardias (VTs) resistant to convetional treatment. Nevertheless, many aspects related to SBRT are currently unknown.Case summaryA 66-year-old man with ischaemic heart disease, a history of coronary artery bypass graft surgery and left ventricular dysfunction was referred for recurrent symptomatic episodes of slow VT (108 b.p.m.). The arrhythmia was resistant to antiarrhythmic drug therapy with amiodarone and repeated catheter ablation. The patient was scheduled to SBRT, however, the first session failed to suppress VT recurrences. After 20 months, the patient underwent re-do ablation procedure that revealed a newly developed scar with its core adjacent to the presumed critical part of the VT substrate. Catheter ablation again failed to eliminate VT and the second session of SBRT was scheduled. To improve targeting of the VT substrate for SBRT, we applied our recently developed original method for integration of data from the electroanatomical mapping system with computer tomography images. The second session of SBRT with precise targeting using the novel strategy led within 3 months to the successful elimination of VT.DiscussionThis case report describes a patient in whom the recurrent VT was abolished only by properly targeted SBRT. Above all, the case highlights the importance of precise identification and targeting for SBRT. Our case also documents in vivo, by electroanatomical voltage mapping, the development of SBRT-related myocardial lesion. This represents an important mechanistic proof of the concept of SBRT.
| S-EPMC7873794 | biostudies-literature