Canadian Partnership for Quality Radiotherapy. Technical Quality Control Guidelines for Gamma Knife Radiosurgery. A guidance document on behalf of:

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Canadian Partnership for Quality Radiotherapy Technical Quality Control Guidelines for Gamma Knife Radiosurgery A guidance document on behalf of: Canadian Association of Radiation Oncology Canadian Organization of Medical Physicists Canadian Association of Medical Radiation Technologists Canadian Partnership Against Cancer June 30, 2016 www.cpqr.ca

Disclaimer All information contained in this document is intended to be used at the discretion of each individual centre to help guide quality and safety program improvement. There are no legal standards supporting this document; specific federal or provincial regulations and licence conditions take precedence over the content of this document. As a living document, the information contained within this document is subject to change at any time without notice. In no event shall the Canadian Partnership for Quality Radiotherapy (CPQR) or its partner associations, the Canadian Association of Radiation Oncology (CARO), the Canadian Organization of Medical Physicists (COMP), and the Canadian Association of Medical Radiation Technologists (CAMRT), be liable for any damages, losses, expenses, or costs whatsoever arising in connection with the use of this document.

Expert Reviewers Anita Berndt Cancer Care Manitoba, Winnipeg, Manitoba Mathieu Guillot Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec Monique van Prooijen Princess Margaret Cancer Centre, Toronto, Ontario External Validation Centre Cancer Care Manitoba, Winnipeg, Manitoba Introduction The Canadian Partnership for Quality Radiotherapy (CPQR) is an alliance amongst the three key national professional organizations involved in the delivery of radiation treatment in Canada: the Canadian Association of Radiation Oncology (CARO), the Canadian Organization of Medical Physicists (COMP), and the Canadian Association of Medical Radiation Technologists (CAMRT). Financial and strategic backing is provided by the federal government through the Canadian Partnership Against Cancer (CPAC), a national resource for advancing cancer prevention and treatment. The mandate of the CPQR is to support the universal availability of high quality and safe radiotherapy for all Canadians through system performance improvement and the development of consensus-based guidelines and indicators to aid in radiation treatment program development and evaluation. This document contains detailed performance objectives and safety criteria for Gamma Knife Radiosurgery. Please refer to the overarching document Technical Quality Control Guidelines for Canadian Radiation Treatment Centres (1) for a programmatic overview of technical quality control, and a description of how the performance objectives and criteria listed in this document should be interpreted. System Description The Gamma Knife (GK) Perfexion (Elekta AB, Stockholm, Sweden) is used to treat intracranial lesions using stereotactic radiosurgery (SRS) procedures. Radiation is delivered by means of 192 ⁶⁰Co sources arranged in rings with a common focus point. (2,3) By distributing the incident radiation over nearly the entire brain, a very large dose can be delivered to a well localized target with minimal harm to healthy brain tissue. These single fraction treatments are a less invasive alternative to cranial surgery. Page 3 of 8

The 1 mm 20 mm ⁶⁰Co sources are encapsulated in bushings and are arranged in eight sectors. The sectors move independently to position a subset of 24 sources over one of three different hole sizes in a tungsten collimator or to an off (blocked) position between holes. This allows the delivery of marbles of radiation (4 mm, 8 mm, or 16 mm shots), which can be combined to conform to the shape of the tumour. Since the different field sizes are created by means of precisely machined collimators, and the radiation is delivered using ⁶⁰Co, much of the variability in dose delivery associated with other external beam devices is eliminated. Dose rates at the centre of an 8 cm radius polystyrene sphere are on the order of 3.5 Gy/min for a newly loaded unit. The sources are enclosed within an iron ball ; additional shielding for scattered radiation is provided by sliding shutters. No primary radiation exits the unit. Before imaging, a frame is fixed to the head of the patient. This serves two purposes: to define a coordinate system common to the imaging, planning, and treatment system, and to ensure that the patient cannot move during treatment. The patient positioning system (PPS; treatment couch) is rigidly affixed to the treatment unit, and the head frame is in turn locked into place on the PPS. Drive motors within the couch automatically position the patient to the prescribed isocentres during treatment. Head frame immobilization and high mechanical reproducibility allow for the accuracy required to deliver large doses to targets near relevant structures within the brain. Related Technical Quality Control Guidelines In order to comprehensively assess GK performance, additional guideline tests, as outlined in related CPQR Technical Quality Control (TQC) guidelines must also be completed and documented, as applicable. Related TQC guidelines, available at cpqr.ca, include: Safety Systems Major Dosimetry Equipment Page 4 of 8

Test Tables Table 1: Daily/Weekly Quality Control Tests Designator Test Performance Tolerance Action Daily D1 GK unit interlocks (frame adapter, side panels) Functional D2 Timer accuracy, linearity 1%, 0.5% 2%, 1% D3 Treatment console alarm test Functional D4 Emergency procedure placards Present Weekly W1 Focus precision test Functional Notes on Daily Tests D1 The GK inhibits beam on if the patient is not locked in place, at the correct gamma angle with the side protection panels engaged. D2 D3 D4 W1 The GK timer agrees with an independent measurement (e.g., stopwatch). Linearity can be tested by cycling through shots of different durations over multiple days. The GK built-in alarm test causes the console alarm to sound. The emergency procedure placards are posted. The GK built-in focus precision test indicates PASS. Table 2: Monthly/Quarterly Quality Control Tests Designator Test Performance Tolerance Action Monthly M1 Clearance test tool check Functional M2 UPS battery check Functional M3 Patient positioning system retraction Functional M4 Patient positioning system accuracy n/a 0.5 mm Page 5 of 8

Quarterly Q1 Sector alignment n/a 0.5/1.0 mm I I 0.5 mm for 4 and 8 mm collimators, 1.0 mm for 16 mm collimator Notes on Monthly/Quarterly Tests M1 M2 M3 M4 Q1 The GK clearance test tool check passes. Also check after possible damage to the tool. At the discretion of the physicist, test frequency may be reduced to semi-annually. The Elekta uninterruptible power supply (UPS) check passes. Disengaging the x/z couch clutch allows the couch to be manually moved in the x/z direction. The position of the patient positioning system must be verified against physical reference positions over an appropriate clinical range in the directions of the three axes (x,y,z). The sectors move to correct alignment with the 4, 8, or 16 mm collimators. Table 3: Annual Quality Control Tests Designator Test Performance Tolerance Action Annual A1 Coincidence of radiation and mechanical isocentre 0.1 mm relative to baseline 0.5 mm absolute A2 Timer linearity 0.5% 1% A3 Timer transit error Baseline A4 Profile accuracy n/a 1 mm A5 Backup timer on GK sector computer Functional A6 Absolute calibration 1% 2% A7 External service dose verification n/a 5% II A8 End-to-end test 1 5%/0.5 mm 1 5%/1.0 mm A9 Radiation leak test Baseline A10 Radiation survey Background Page 6 of 8

A11 Independent quality control review Complete II After each major maintenance and then every other year; tolerance as per testing institution (e.g., Imaging and Radiation Oncology Core [IROC]). Notes on Annual Tests A1 A2 A3 A4 A5 A6 A7 A8 The positions of the radiation and mechanical isocentres agree with each other. The GK timer is linear. Test over a larger range than daily testing. The transit error is consistent with that measured during commissioning. The measured profiles agree with those in the treatment planning system. Stated tolerance applies to the 50% isodose line for each collimator size. The backup timer on the GK sector computer agrees with the console computer. The absolute dose rate in the treatment planning system matches the measured dose rate. Measurements must be made with a calibrated chamber using an accepted protocol (e.g., TG-21 (4) ). The absolute dose is independently verified by an external service (e.g., IROC Houston OSLD/TLD [optically-stimulated/thermoluminescent dosimeter] Monitoring Program). An end-to-end phantom test is performed including frame placement, imaging, treatment planning, treatment, and verification that the intended treatment was delivered with the stated dose and positioning accuracy. The dosimetric accuracy depends on the dosimeter being used. For example, 1% accuracy would apply when using an ion chamber, whereas 5% would be appropriate for film. A9 10 The configuration of these tests will depend on the design of the facility and equipment. As a minimum, Canadian Nuclear Safety Commission (CNSC) license conditions and applicable regulations must be followed. A11 To ensure redundancy and adequate monitoring, a second qualified medical physicist must independently verify the implementation, analysis, and interpretation of the quality control tests at least annually. Page 7 of 8

Acknowledgements We would like to thank the many people who participated in the production of this guideline. These include: Kyle Malkoske and Laurent Tantôt (associate editors); the Quality Assurance and Radiation Safety Advisory Committee; the COMP Board of Directors, Erika Brown and the CPQR Steering Committee, and all individuals that submitted comments during the community review of this guideline. References 1. Canadian Partnership for Quality Radiotherapy. Technical quality control guidelines for Canadian radiation treatment centres. 2016 May 1. Available from: http://www.cpqr.ca/programs/technicalquality-control 2. Gamma Knife (GK) Perfexion, Elekta AB. 2015 [cited 2016 Jul 19]. Available from: http://www.elekta.com/healthcare-professionals/products/elekta-neuroscience/gamma-knifesurgery/gamma-knife-perfexion.html 3. Leksell Gamma Knife Perfexion Instruction for Use, Elekta AB. 2007. Available from: https://www.elekta.com/radiosurgery/leksell-gamma-knife-perfexion.html 4. Task Group 21, Radiation Therapy Committee, AAPM. A protocol for the determination of absorbed dose from high-energy photon and electron beams. Med. Phys. 1983;10:741 771. Page 8 of 8