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The clinical use of surface imaging has increased dramatically, with demonstrated utility for initial patient positioning, real-time motion monitoring, and beam gating in a variety of anatomical sites. The Therapy Physics Subcommittee and the Imaging for Treatment Verification Working Group of the American Association of Physicists in Medicine commissioned Task Group 302 to review the current clinical uses of surface imaging and emerging clinical applications. The specific charge of this task group was to provide technical guidelines for clinical indications of use for general positioning, breast deep-inspiration breath hold treatment, and frameless stereotactic radiosurgery. Additionally, the task group was charged with providing commissioning and on-going quality assurance (QA) requirements for surface-guided radiation therapy (SGRT) as part of a comprehensive QA program including risk assessment. Workflow considerations for other anatomic sites and for computed tomography simulation, including motion management, are also discussed. Finally, developing clinical applications, such as stereotactic body radiotherapy (SBRT) or proton radiotherapy, are presented. The recommendations made in this report, which are summarized at the end of the report, are applicable to all video-based SGRT systems available at the time of writing., (© 2022 The Authors. Medical Physics published by Wiley Periodicals LLC on behalf of American Association of Physicists in Medicine.)

AlignRT is a surface imaging system that has been utilized for localizing and tracking patient position during radiotherapy. AlignRT has two calibration procedures that can set the system's isocenter called "Monthly Calibration" (MC) and "Isocentre Calibration" (IC). The MC utilizes a calibration plate. In addition to the calibration plate, the IC utilizes a cubic phantom that is imaged with the linac treatment beam to aid in aligning the AlignRT and treatment-beam isocenters. This work evaluated the effects of misaligning the calibration plate during the calibration process. The plate was intentionally shifted away from isocenter ±3.0 mm in the longitudinal and lateral directions and ±1.0 mm in the longitudinal, lateral, and vertical directions. A mock stereotactic radiosurgery (SRS) treatment was used to evaluate the effects of the miscalibrations. An anthropomorphic head phantom was placed in an SRS treatment position and monitored with the AlignRT system. The AlignRT-indicated offsets were recorded at 270°, 315°, 0°, 45°, and 90° couch angles for each intentional misalignment of the calibration plate during the MC. The IC was also performed after each miscalibration, and the measurements were repeated and compared to the previous results. With intentional longitudinal and lateral shifts of ±3.0 mm and ±1.0 mm of the calibration plate, the average indicated offsets at couch rotations of ±90° were 4.3 mm and 1.6 mm, respectively. This was in agreement with the theoretical offset of √2*(shift-of-the-calibration plate). Since vertical shifts were along the rotation axis of the couch, these shifts had little effect on the offsets with changing couch angle. When the IC was applied, the indicated offsets were all within 0.5 mm for all couch angles for each of the miscalibrations. These offsets were in agreement with the known magnitude of couch walkout. The IC method effectively removes the potential miscalibration artifacts of the MC method due to misalignments of the calibration plate., (© 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.)

Purpose: In surface image guided radiosurgery, action limits are created to determine at what point intrafractional motion exhibited by the patient is large enough to warrant intervention. Action limit values remain constant across patients despite the fact that patient motion affects the target coverage of brain metastases differently depending on the planning technique and other treatment plan-specific factors. The purpose of this work was twofold. The first purpose was to characterize the sensitivity of single-met per iso and multimet per iso treatment plans to uncorrected patient motion. The second purpose was to describe a method to prospectively determine treatment plan-specific action limits considering this sensitivity., Methods: In their surface image guided radiosurgery technique, patient positioning is achieved with a thermoplastic mask that does not cover the patient's face. The patient's exposed face is imaged by a stereoscopic photogrammetry system. It is then compared to a reference surface and monitored throughout treatment. Seventy-two brain metastases (representing 29 patients) were used for this study. Twenty-five mets were treated individually ("single-met per iso plans"), and 47 were treated in a plan simultaneously with at least one other met ("multimet per iso plans"). For each met, the proportion of the gross tumor volume that remained within the 100% prescription isodose line was estimated under the influence of combinations of translations and rotations (0.0-3.0 mm and 0.0°-3.0°, respectively). The target volume and the prescription dose-volume were considered concentric spheres that each encompassed a volume determined from the treatment plan. Plan-specific contour plots and DVHs were created to illustrate the sensitivity of a specific lesion to uncorrected patient motion., Results: Both single-met per iso and multimet per iso plans exhibited compromised target coverage under translations and rotations, though multimet per iso plans were considerably more sensitive to these transformations (2.3% and 39.8%, respectively). Plan-specific contour plots and DVHs were used to illustrate how size, distance from isocenter, and planning technique affect a particular met's sensitivity to motion., Conclusions: Stereotactic radiosurgery treatment plans that treat multiple brain metastases using a common isocenter are particularly susceptible to compromised target coverage as a result of uncorrected patient motion. The use of such a planning technique along with other treatment plan-specific factors should influence patient motion management. A graphical representation of the effect of translations and rotations on any particular plan can be generated to inform clinicians of the appropriate action limit when monitoring intrafractional motion.

Purpose: Surface image guided, Linac-based radiosurgery (SIG-RS) is a modern approach for delivering radiosurgery that utilizes optical stereoscopic imaging to monitor the surface of the patient during treatment in lieu of using a head frame for patient immobilization. Considering the novelty of the SIG-RS approach and the severity of errors associated with delivery of large doses per fraction, a risk assessment should be conducted to identify potential hazards, determine their causes, and formulate mitigation strategies. The purpose of this work is to investigate SIG-RS using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA), report on the effort required to complete the analysis, and evaluate the use of FTA in conjunction with FMEA., Methods: A multidisciplinary team was assembled to conduct the FMEA on the SIG-RS process. A process map detailing the steps of the SIG-RS was created to guide the FMEA. Failure modes were determined for each step in the SIG-RS process, and risk priority numbers (RPNs) were estimated for each failure mode to facilitate risk stratification. The failure modes were ranked by RPN, and FTA was used to determine the root factors contributing to the riskiest failure modes. Using the FTA, mitigation strategies were formulated to address the root factors and reduce the risk of the process. The RPNs were re-estimated based on the mitigation strategies to determine the margin of risk reduction., Results: The FMEA and FTAs for the top two failure modes required an effort of 36 person-hours (30 person-hours for the FMEA and 6 person-hours for two FTAs). The SIG-RS process consisted of 13 major subprocesses and 91 steps, which amounted to 167 failure modes. Of the 91 steps, 16 were directly related to surface imaging. Twenty-five failure modes resulted in a RPN of 100 or greater. Only one of these top 25 failure modes was specific to surface imaging. The riskiest surface imaging failure mode had an overall RPN-rank of eighth. Mitigation strategies for the top failure mode decreased the RPN from 288 to 72., Conclusions: Based on the FMEA performed in this work, the use of surface imaging for monitoring intrafraction position in Linac-based stereotactic radiosurgery (SRS) did not greatly increase the risk of the Linac-based SRS process. In some cases, SIG helped to reduce the risk of Linac-based RS. The FMEA was augmented by the use of FTA since it divided the failure modes into their fundamental components, which simplified the task of developing mitigation strategies.

Background: Frameless stereotactic radiosurgery is commonly used to treat intracranial metastases, but mask-based immobilization can be uncomfortable for patients., Objective: To describe the clinical outcomes using a novel real-time, frameless, surface imaging--guided radiosurgery (SIG-RS) technique to treat brain metastases., Methods: Data were prospectively gathered for 44 consecutive patients totaling 115 intracranial metastases treated with SIG-RS in a median of 1 fraction (range, 1-5) to a median dose of 20 Gy (range, 15-30 Gy). Local control, regional control, and overall survival were estimated by the Kaplan-Meier method., Results: Median follow-up for all patients was 6.0 months (range, 0.3-21.6 months), with 31 of 44 (70%) deceased at the time of analysis. The 35 patients (80%) with follow-up imaging totaled 88 lesions evaluable for local control. Actuarial 6- and 12-month local control was 90% (95% confidence interval, 82-98) and 76% (95% confidence interval, 60-91), respectively. Regional failure was observed in 16 patients (46%). The median actuarial overall survival was 7.7 months (95% confidence interval, 5.7-9.7). Analysis of the subset of 22 patients (55 lesions) who received SIG-RS alone (no prior treatment) in a single fraction yielded comparable clinical outcomes. Grade 3 or greater toxicity occurred in 4 patients (9%). The median treatment time from beam on to beam off was 15 minutes (range, 3-36 minutes)., Conclusion: SIG-RS for treating intracranial metastases can produce clinical outcomes comparable to those with conventional frame-based and frameless stereotactic radiosurgery techniques while providing greater patient comfort with an open-faced mask and fast treatment times.

Rotational RapidArc (RA) and static intensity-modulated radiosurgery (IMRS) have been used for brain radiosurgery. This study compares the 2 techniques from beam delivery parameters and dosimetry aspects for multiple brain metastases. Twelve patients with 2-12 brain lesions treated with IMRS were replanned using RA. For each patient, an optimal 2-arc RA plan from several trials was chosen for comparison with IMRS. Homogeneity, conformity, and gradient indexes have been calculated. The mean dose to normal brain and maximal dose to other critical organs were evaluated. It was found that monitor unit (MU) reduction by RA is more pronounced for cases with larger number of brain lesions. The MU-ratio of RA and IMRS is reduced from 104% to 39% when lesions increase from 2 to 12. The dose homogeneities are comparable in both techniques and the conformity and gradient indexes and critical organ doses are higher in RA. Treatment time is greatly reduced by RA in intracranial radiosurgery, because RA uses fewer MUs, fewer beams, and fewer couch angles., (Copyright © 2012 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.)

The optically-guided frameless system (OFLS) has been used in our clinic for intracranial stereotactic radiosurgery (SRS) since 2006, as it is especially effective in IMRT-based radiosurgery (IMRS), which allows treating multiple brain lesions simultaneously using single isocenter approach. This study reports our retrospective analysis of patient setup accuracy using this system. The OFLS consists of a bite block with fiducial markers and an infra-red camera system. To test reproducibility, patients are taken for reseat verification after bite block construction. Upon the completion of radiosurgery planning, the isocenter position(s) and images are sent to the optical guidance computer where fiducials are manually registered from the CT scan. During treatment, patient setup is monitored and guided by the camera readings on the fiducials. In addition, two orthogonal kV images are acquired and used as an isocenter verification tool. In addition, we have analyzed the reseat and fiducial digitization data of 56 patients. Retrospective comparison of kV images with reference images has been carried out for all the patients to evaluate actual patient setup accuracy at the time of treatment. The histogram of the findings shows that 82.2% of patients had 3D isodisplacement (E < or = 1 mm; 5.2% had 1< E < or = 2 mm). Hence, for 87.5 % of the patients in the study, treatments were finished under the optical guidance with a maximum setup error of 2 mm and the median setup error of 0 mm. For the remaining 12.5% of patients in the study, the isodisplacements were greater than 2 mm and the treatment records showed that those patients were repositioned, guided by the orthogonal kV-images. It is found that the OFLS in the SRS treatment has acceptable accuracy when used in conjunction with orthogonal kV images, and the use of orthogonal kV images as a verification tool ensures the efficacy of frameless localization in the radiosurgery treatment.

Currently, high-precision delivery in stereotactic radiosurgery (SRS) is achieved via high-precision target localization and rigid patient immobilization. Rigid patient immobilization can result in, however, patient discomfort, which is exacerbated by the long duration of SRS treatments and may induce patient movement. To address this issue, we developed a new SRS technique that is aimed to minimize patient discomfort while maintaining high-precision treatment, based on a less-rigid patient immobilization combined with continuous patient motion monitoring. In this paper, we examine the feasibility of this new technique. An anthropomorphic head phantom is used to check the accuracy of a 3D surface imaging system that provides the monitoring. Volunteers are used to study patient motion inside a new type of head mold that is used for minimal immobilization. Results show that for different couch angles, the difference between the phantom positions recorded by the surface imaging system and by an infrared optical tracking system was within 1 mm in displacements and 1 degrees in rotation. The motion detected by both systems during couch shifts is within 1 mm agreement. The average maximum volunteer head motion in the head mold during the 20 min interval in any direction was 0.7 mm (range: 0.4-1.1 mm). Patient motion due to couch motion was always less than 0.2 mm. We conclude that motion inside the minimally immobilizing head mold is small and can be accurately detected by real-time surface imaging.

We have employed a frameless localization system for intracranial radiosurgery, utilizing a custom biteblock with fiducial markers and an infra-red camera for set-up and monitoring patient position. For multiple brain metastases or large irregular lesions, we use a single-isocenter intensity-modulated approach. We report our quality assurance measurements and our experience using Intensity Modulated Radiosurgery (IMRS) to treat such intracranial lesions. A phantom with integrated targets and fiducial markers was utilized to test the positional accuracy of the system. The frameless localization system was used for patient setup and target localization as well as for motion monitoring during treatment. Inverse optimization planning gave satisfactory dose coverage and critical organ sparing. Patient setup was guided by the infrared camera through fine adjustment in three translational and three rotational degrees for isocenter localization and verified by orthogonal kilovoltage (kV) images, taken before treatment to ensure the accuracy of treatment. The relative localization of the camera based system was verified to be highly accurate along three translational directions of couch motion and couch rotation. After verification, we began treating patients with this technique. About 8-12 properly selected fixed beams with a single isocenter were sufficient to achieve good dose coverage and organ sparing. Portal dosimetry with an Electronic Portal Imaging Device (EPID) and kV images provided excellent quality assurance for the IMRS plan and patient setup. The treatment time was less than 60 min to deliver doses of 16-20 Gy in a single fraction. The camera-based system was verified for positional accuracy and was deemed sufficiently accurate for stereotactic treatments. Single isocenter IMRS treatment of multiple brain metastases or large irregular lesions can be done within an acceptable treatment time and gives the benefits of dose-conformity and organ-sparing, easy plan QA, and patient setup verification.

Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer., Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (<3 months) and late (>6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (International Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specific antigen (PSA) response are analyzed., Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir

The CyberKnife is a complex, emerging technology that is a significant departure from current stereotactic radiosurgery and external beam radiotherapy technologies. In its clinical application and quality assurance (QA) approach, the CyberKnife is currently situated somewhere in between stereotactic radiosurgery and radiotherapy. The clinical QA for this image-guided treatment delivery system typically follows the vendor's guidance, mainly because of the current lack of vendor-independent QA recommendations. The problem has been exacerbated because very little published data are available for QA for the CyberKnife system, especially for QA of the interaction between individual system components. The tools and techniques for QA of the CyberKnife are under development and will continue to improve with longer clinical experience of the users. The technology itself continues to evolve, forcing continuous changes and adaptation of QA. To aid in the process of developing comprehensive guidance on CyberKnife QA, a database of errors based on users reporting incidents and corrective actions would be desirable. The goal of this work was to discuss the status of QA guidelines in the clinical implementation of the CyberKnife system. This investigation was done from the perspective of an active clinical and research site using the CyberKnife.

The purpose of this work is to provide background and current directions of image guidance for localized prostate cancer treatments. We will describe the external beam hypofractionation protocol for localized prostate cancer currently in progress at Stanford University and the biological bases for large fractions in an abbreviated treatment course for prostate cancer. The need for image guidance in external beam prostate cancer treatments will be discussed. Our experience with two imageguided implementations of hypofractionated radiotherapy for localized prostate cancer will be presented. These are the Cyberknife System (Accuray, Inc.) and the Trilogy System (Varian Medical Systems, Inc.).

Purpose: Both humans and software are notoriously challenging to account for in traditional hazard analysis models. The purpose of this work is to investigate and demonstrate the application of a new, extended accident causality model, called systems theoretic accident model and processes (STAMP), to radiation oncology. Specifically, a hazard analysis technique based on STAMP, system-theoretic process analysis (STPA), is used to perform a hazard analysis. Methods: The STPA procedure starts with the definition of high-level accidents for radiation oncology at the medical center and the hazards leading to those accidents. From there, the hierarchical safety control structure of the radiation oncology clinic is modeled, i.e., the controls that are used to prevent accidents and provide effective treatment. Using STPA, unsafe control actions (behaviors) are identified that can lead to the hazards as well as causal scenarios that can lead to the identified unsafe control. This information can be used to eliminate or mitigate potential hazards. The STPA procedure is demonstrated on a new online adaptive cranial radiosurgery procedure that omits the CT simulation step and uses CBCT for localization, planning, and surface imaging system during treatment. Results: The STPA procedure generated a comprehensive set of causal scenarios that are traced back to system hazards and accidents. Ten control loops were created for the new SRS procedure, which covered the areas of hospital and department management, treatment design and delivery, and vendor service. Eighty three unsafe control actions were identified as well as 472 causal scenarios that could lead to those unsafe control actions. Conclusions: STPA provides a method for understanding the role of management decisions and hospital operations on system safety and generating process design requirements to prevent hazards and accidents. The interaction of people, hardware, and software is highlighted. The method of STPA produces results that can be used to improve safety and prevent accidents and warrants further investigation. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To evaluate the initial clinical experience with a frameless and maskless technique for stereotactic radiosurgery using minimal patient immobilization and real-time patient motion monitoring during treatment. We focus on the evaluation of the patient treatment process. Methods and Materials: The study considered the first 23 patients treated with this technique. Head positioning was achieved with a patient-specific head mold made out of expandable foam that conforms to the patient''s head. The face of the patient is left open for maximal comfort and so that motion of a region of interest consisting of the forehead, nose, eyes, and temporal bones can be monitored during treatment using a video surface imaging system (VisionRT Inc, London, UK). Initial setup of the patient was performed with the surface imaging system using the surface of the patient obtained from the treatment planning computed tomographic (CT) scan. The initial setup was confirmed and finalized with cone-beam CT (CBCT) prior to treatment. The shifts for final setup based on the CBCT and the duration of all the steps in the treatment process were recorded. Patients were monitored during treatment with surface imaging, and a beam hold-off was initiated when the patient''s motion exceeded a prespecified tolerance. Results: The average total setup time including surface imaging and CBCT was 26 minutes, while the portion corresponding to surface imaging was 14 minutes. The average treatment time from when the patient was placed on the treatment table until the last treatment beam was 40 minutes. Eight (35%) patients needed repositioning during the treatment. The average shifts identified from CBCT after initial setup with surface imaging were 1.85 mm in the anterior-posterior direction, and less than 1.0 mm in the lateral and superior-inferior directions. The longest treatment times (including beam hold-offs) happened for patients who fell asleep on the treatment table and were moving involuntarily. Conclusions: The frameless and maskless treatment using minimal immobilization and surface imaging has proven to be reasonably fast for routine clinical use. We observed that patient compliance is important. An additional degree of semi-rigid immobilization would be helpful for patients who fall asleep and involuntarily move during the procedure. [Copyright &y& Elsevier]