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Title: Process-based quality management for clinical implementation of adaptive radiotherapy

Abstract

Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200more » were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations.« less

Authors:
; ; ;  [1]
  1. Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110 (United States)
Publication Date:
OSTI Identifier:
22409572
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 41; Journal Issue: 8; Other Information: (c) 2014 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; HAZARDS; MANAGEMENT; PATIENTS; PLANNING; QUALITY ASSURANCE; QUALITY CONTROL; RADIOTHERAPY; RISK ASSESSMENT

Citation Formats

Noel, Camille E., Santanam, Lakshmi, Parikh, Parag J., and Mutic, Sasa, E-mail: smutic@radonc.wustl.edu. Process-based quality management for clinical implementation of adaptive radiotherapy. United States: N. p., 2014. Web. doi:10.1118/1.4890589.
Noel, Camille E., Santanam, Lakshmi, Parikh, Parag J., & Mutic, Sasa, E-mail: smutic@radonc.wustl.edu. Process-based quality management for clinical implementation of adaptive radiotherapy. United States. doi:10.1118/1.4890589.
Noel, Camille E., Santanam, Lakshmi, Parikh, Parag J., and Mutic, Sasa, E-mail: smutic@radonc.wustl.edu. Fri . "Process-based quality management for clinical implementation of adaptive radiotherapy". United States. doi:10.1118/1.4890589.
@article{osti_22409572,
title = {Process-based quality management for clinical implementation of adaptive radiotherapy},
author = {Noel, Camille E. and Santanam, Lakshmi and Parikh, Parag J. and Mutic, Sasa, E-mail: smutic@radonc.wustl.edu},
abstractNote = {Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations.},
doi = {10.1118/1.4890589},
journal = {Medical Physics},
number = 8,
volume = 41,
place = {United States},
year = {Fri Aug 15 00:00:00 EDT 2014},
month = {Fri Aug 15 00:00:00 EDT 2014}
}
  • Online adaptive radiation therapy has the potential to ensure delivery of optimal treatment to the patient by accounting for anatomical and potentially functional changes that occur from one fraction to the next and over the course of treatment. While on-line adaptive RT (ART) has been a topic of many publications, discussions, and research, it has until very recently remained largely a concept and not a practical implementation. However, recent advances in on-table imaging, use of deformable image registration for contour generation and dose tracking, faster and more efficient plan optimization, as well as fast quality assurance method has enabled themore » implementation of ART in the clinic in the past couple of years. The introduction of these tools into routine clinical use requires many considerations and progressive knowledge to understand how processes that have historically taken hours/days to complete can now be done in less than 30 minutes. This session will discuss considerations to perform real time contouring, planning and patient specific QA, as well as a practical workflow and the required resources. Learning Objectives: To understand the difficulties, challenges and available technologies for online adaptive RT. To understand how to implement online adaptive therapy in a clinical environment and to understand the workflow and resources required. To understand the limitations and sources of uncertainty in the online adaptive process I have research funding from ViewRay Inc. and Philips Medical Systems.; R. Kashani, I have research funding from ViewRay Inc. and Philips Medical Systems.; X. Li, Research supported by Elekta Inc.« less
  • Purpose: We developed and evaluated a correction strategy for prostate rotations using direct adaptation of segments in intensity-modulated radiotherapy (IMRT). Method and Materials: Implanted fiducials (four gold markers) were used to determine interfractional translations, rotations, and dilations of the prostate. We used hybrid imaging: The markers were automatically detected in two pretreatment planar X-ray projections; their actual position in three-dimensional space was reconstructed from these images at first. The structure set comprising prostate, seminal vesicles, and adjacent rectum wall was transformed accordingly in 6 degrees of freedom. Shapes of IMRT segments were geometrically adapted in a class solution forward-planning approach,more » derived within seconds on-site and treated immediately. Intrafractional movements were followed in MV electronic portal images captured on the fly. Results: In 31 of 39 patients, for 833 of 1013 fractions (supine, flat couch, knee support, comfortably full bladder, empty rectum, no intraprostatic marker migrations >2 mm of more than one marker), the online aperture adaptation allowed safe reduction of margins clinical target volume-planning target volume (prostate) down to 5 mm when only interfractional corrections were applied: Dominant L-R rotations were found to be 5.3 Degree-Sign (mean of means), standard deviation of means {+-}4.9 Degree-Sign , maximum at 30.7 Degree-Sign . Three-dimensional vector translations relative to skin markings were 9.3 {+-} 4.4 mm (maximum, 23.6 mm). Intrafractional movements in 7.7 {+-} 1.5 min (maximum, 15.1 min) between kV imaging and last beam's electronic portal images showed further L-R rotations of 2.5 Degree-Sign {+-} 2.3 Degree-Sign (maximum, 26.9 Degree-Sign ), and three-dimensional vector translations of 3.0 {+-}3.7 mm (maximum, 10.2 mm). Addressing intrafractional errors could further reduce margins to 3 mm. Conclusion: We demonstrated the clinical feasibility of an online adaptive image-guided, intensity-modulated prostate protocol on a standard linear accelerator to correct 6 degrees of freedom of internal organ motion, allowing safe and straightforward implementation of margin reduction and dose escalation.« less
  • Purpose: In 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 Materials: Participants 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 asmore » proton beam therapy, and the international harmonization of clinical trial QA. Results: Four 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. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.« less
  • Purpose: To evaluate the clinical implementation of an online adaptive plan-of-the-day protocol for nonrigid target motion management in locally advanced cervical cancer intensity modulated radiation therapy (IMRT). Methods and Materials: Each of the 64 patients had four markers implanted in the vaginal fornix to verify the position of the cervix during treatment. Full and empty bladder computed tomography (CT) scans were acquired prior to treatment to build a bladder volume-dependent cervix-uterus motion model for establishment of the plan library. In the first phase of clinical implementation, the library consisted of one IMRT plan based on a single model-predicted internal targetmore » volume (mpITV), covering the target for the whole pretreatment observed bladder volume range, and a 3D conformal radiation therapy (3DCRT) motion-robust backup plan based on the same mpITV. The planning target volume (PTV) combined the ITV and nodal clinical target volume (CTV), expanded with a 1-cm margin. In the second phase, for patients showing >2.5-cm bladder-induced cervix-uterus motion during planning, two IMRT plans were constructed, based on mpITVs for empty-to-half-full and half-full-to-full bladder. In both phases, a daily cone beam CT (CBCT) scan was acquired to first position the patient based on bony anatomy and nodal targets and then select the appropriate plan. Daily post-treatment CBCT was used to verify plan selection. Results: Twenty-four and 40 patients were included in the first and second phase, respectively. In the second phase, 11 patients had two IMRT plans. Overall, an IMRT plan was used in 82.4% of fractions. The main reasons for selecting the motion-robust backup plan were uterus outside the PTV (27.5%) and markers outside their margin (21.3%). In patients with two IMRT plans, the half-full-to-full bladder plan was selected on average in 45% of the first 12 fractions, which was reduced to 35% in the last treatment fractions. Conclusions: The implemented online adaptive plan-of-the-day protocol for locally advanced cervical cancer enables (almost) daily tissue-sparing IMRT.« less
  • Purpose: To evaluate the clinical potential of deformable image registration (DIR)-based automatic propagation of physician-drawn contours from a planning CT to midtreatment CT images for head and neck (H and N) adaptive radiotherapy. Methods: Ten H and N patients, each with a planning CT (CT1) and a subsequent CT (CT2) taken approximately 3–4 week into treatment, were considered retrospectively. Clinically relevant organs and targets were manually delineated by a radiation oncologist on both sets of images. Four commercial DIR algorithms, two B-spline-based and two Demons-based, were used to deform CT1 and the relevant contour sets onto corresponding CT2 images. Agreementmore » of the propagated contours with manually drawn contours on CT2 was visually rated by four radiation oncologists in a scale from 1 to 5, the volume overlap was quantified using Dice coefficients, and a distance analysis was done using center of mass (CoM) displacements and Hausdorff distances (HDs). Performance of these four commercial algorithms was validated using a parameter-optimized Elastix DIR algorithm. Results: All algorithms attained Dice coefficients of >0.85 for organs with clear boundaries and those with volumes >9 cm{sup 3}. Organs with volumes <3 cm{sup 3} and/or those with poorly defined boundaries showed Dice coefficients of ∼0.5–0.6. For the propagation of small organs (<3 cm{sup 3}), the B-spline-based algorithms showed higher mean Dice values (Dice = 0.60) than the Demons-based algorithms (Dice = 0.54). For the gross and planning target volumes, the respective mean Dice coefficients were 0.8 and 0.9. There was no statistically significant difference in the Dice coefficients, CoM, or HD among investigated DIR algorithms. The mean radiation oncologist visual scores of the four algorithms ranged from 3.2 to 3.8, which indicated that the quality of transferred contours was “clinically acceptable with minor modification or major modification in a small number of contours.” Conclusions: Use of DIR-based contour propagation in the routine clinical setting is expected to increase the efficiency of H and N replanning, reducing the amount of time needed for manual target and organ delineations.« less