PET Steering Committee Meeting Minutes. Thursday, June 18 th, 2015 Time: 1:30 3:30 pm

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1 PET Steering Committee Meeting Minutes Thursday, June 18 th, 2015 Time: 1:30 3:30 pm Committee Members Present: U. Metser (Chair), R. dekemp, D. Hussey, K. Kingsbury, A. Singnurkar Other Attendees: C. Bedford, J. Burneo, D. Langer, P. MacCrostie, V. Mak, B. Monaghan, R. Poon, C. Snead, S. Su-Myat, J. Wang Regrets: R. Beanlands, C. Caldwell, J. Dobranowski, M. Freeman, M. Greenberg, S. Houle, R. M. Iwanochko, A. Swaminath, Y. Ung Business 1. Opening Remarks 1.1. The Agenda was approved as circulated The May minutes were approved as circulated Updates from the Chair Based on initial guidance from Health Canada, the PET MUSE clinical trial will be performed under a clinical trials agreement (CTA) for use of FDG; the application has been filed for the required approvals. Further discussion has suggested that the purpose of the CTA would be to enable a manufacturer to add the indication to the product monograph for FDG, which is not the intent of the current trial(s). Health Canada is compiling a list of approved indications for FDG-PET across Canada, and looking to better define what is considered off label. There may be opportunities to discuss further through an annual meeting attended by both Health Canada and members of the PET community. Action Item: Follow up on regulatory requirements for FDG and/or other radiopharmaceuticals with respect to clinical trials. 2. Insured/Uninsured Program Updates 2.1. Insured Program Funding packages for PET centres (hospital-based and Independent Health Facilities (IHFs)) for fiscal year 2015/2016 are in development based on the projected volumes provided by the PET centres. FDG costing information has been received and built into this year s reimbursement rates Uninsured Program PET Access Program expert reviewer recruitment update

2 The PET Access Program received multiple responses to the Expression of Interest (EOI) posted in February All candidates have been vetted and offers have been extended to selected candidates to join the program to form a third panel of experts PET Access Program referrals There have been ongoing discussions on how to improve the PET Access Program referral process to streamline the process for referring physicians and improve completeness of the initial request. The majority of physicians who refer through PET Access do so only a couple of times per year (maximum) and therefore are not familiar with submission requirements. The referral process will be reviewed to identify improvements, increasing the efficiency of the referral process and providing a more positive experience for physicians using the program. Action Item: Evaluate the referral process and identify key areas where changes can be made to improve communication between the PET Access Program and referring physicians, including possible enhancements to the PET etool. 3. Epilepsy Clinical Cases Currently there are ~100,000 Ontarians with epilepsy; ~30,000 of these have medically refractory epilepsy and should be considered for epilepsy surgery. PET scanning has been critical and valuable in the surgical management of a wide variety of patients and is also used to spare patients from unnecessary surgery. PET scanning has a role in localizing the epileptogenic focus of seizures in order to plan surgery in cases where there is discordance between the EEG/MEG/MRI results and there is either no lesion or a subtle lesion seen on MRI. Approximately 250 epilepsy surgeries are currently performed in the province of Ontario on a yearly basis. (50 pediatric surgeries at The Hospital for Sick Children and 200 adult surgeries between London Health Sciences and Toronto Western Hospital combined). To improve care for epilepsy patients, the provincial epilepsy working group has a mandate to increase this number. The estimated volume of PET scans per year to assist with surgical guidance is a maximum of 500 PET scans across the province, including both adult and pediatric indications. It was noted that in this case approximately pediatric PET scans would be performed at The Hospital of Sick Children Pediatric Epilepsy Clinical Cases Approximately 30-40% of pediatric cases who have had an MEG at The Hospital for Sick Children have required a PET scan to localize the epileptogenic focus in the last 4 years. The Hospital for Sick Children uses fusion images to localize the epileptogenic focus. The first pediatric case presented involved a male pediatric patient with focal epilepsy from the left temporal lobe. The PET scan results showed an area of hypometabolism concordant with the subtle lesion seen with the MEG.

3 The second pediatric case presented showed how the PET scan results helped place intracranial electrodes in order to determine the epileptogenic focus, as the PET scan results were not concordant with the MEG results. The final pediatric case presented involved a female young adolescent with atrophy in the right brain and a suspected diagnosis of Rasmussen s disease based on the MEG results. The PET scan showed significant hypometabolism on the entire right side of the brain, confirming the diagnosis of Rasmussen s Adult Epilepsy Clinical Cases The first adult case presented appeared to have frontal lobe epilepsy, however the MRI was normal and the EEG was not helpful. The patient was having mostly nocturnal seizures and therefore an ictal SPECT was not possible. The PET scan showed an area of hypometabolism and helped place the intracranial electrodes which showed the same epileptogenic focus area as seen on the PET scan. The patient had surgery and has been seizure free ever since. The second adult case presented with a history of what appeared to be left temporal lobe epilepsy. The PET scan result showed a possible epileptogenic focus in the orbital frontal lobe. Intracranial electrodes were place in both the left temporal and the orbital frontal lobes which resulted in confirmation that the epileptogenic focus was just in the left temporal lobe. 4. Epilepsy Registry Update In late 2014 both the Epilepsy Task Force and the PET Steering Committee recommended the development of a Registry to gather more data on the use of FDG-PET scanning in the pre-surgical evaluation of adult and pediatric patients with medically intractable epilepsy. Pre- and post-pet scan data collection forms have been drafted for review by the PET Steering Committee to measure the impact of PET scanning on epilepsy surgery planning. Recommended updates to the data collection forms are as follows: The portion of the post-pet scan form to be completed by the PET Centre outlining the areas of hypometabolism found on the PET scan is to be updated to match the suspected epileptogenic focus areas on the pre-pet scan form. An additional section will be added to the PET Centre portion of the post-pet scan form asking if the PET scan results were concordant with other findings. The Engel classification system will be added to the post-pet scan form. (The Engel classification system measures surgical outcomes and is applied one year post surgery, i.e., class 1 = free of disabling seizures; class II = rare disabling seizures; class III = worthwhile improvement; class IV = no worthwhile improvement). The referring physician will be asked to complete this portion of the form for all surgical patients 1 year post-surgery to measure the success of the PET scan in directing surgery.

4 Currently there is no province-wide standardization for PET scan reporting in epilepsy. It will be recommended that the PET centres participating in the upcoming Epilepsy Registry download the available free reporting software for epilepsy PET scans prior to the launch of the Registry. It will also be recommended that each of the participating PET centres agree on the assessment criteria, (i.e., visual assessment + 2 Standard Deviations) prior to the Registry launch. One final element discussed is the use of PET-MRI for this Registry as both London Health Sciences and the University Health Network (UHN) have access to PET-MRI. Research Ethics Board requirements need to be explored. If PET-MRI is an option for the Epilepsy Registry, post-pet scan data collection form will need to be updated to capture whether a PET-CT or PET-MRI was used. Action Item: Update the draft Registry data collection forms with the recommendations listed above; ensure the PET centres involved in the Registry are using the same reporting software and agree on the assessment criteria prior to Registry launch; confirm if REB is required to include PET- MRI; add a representative from UHN to the committee developing the Registry so that all PET centres involved are represented. 5. QA Subcommittee Update The Quality Assurance (QA) Subcommittee was formed in late 2013 to address both the technical side of QA in PET as well as the clinical side, such as peer-review. The QA Subcommittee is developing a Best Practices document to ensure PET scanning in Ontario continues to be of high quality, and will encompass all aspects of PET scanning. The first draft of the Best Practices document was circulated for review by the PET Steering Committee in November Upon completion it will be shared with all PET centres in the province for their review and feedback. It contains guidelines and benchmarks which are recommendations to help set up a common standard across the province. It is thought that these recommendations may eventually be brought forth to the licensing/accreditation bodies to supplement their requirements. The Chair of the committee has recently stepped down and two additional members of the committee have been approached to co-chair and continue to move the work forward. Next steps for the QA Subcommittee will be to set short term, medium term, and long term goals. Short Term Goal: As the Ontario Clinical Oncology Group (OCOG) had previously developed a QA document for clinical trials and the PET MUSE trial will be launching by the end of 2015, refining the recommendations for the Clinical Trials portion of the Best Practices document will be the first priority. The committee will refer to the OCOG QA document for guidance. This will form the foundation for the rest of the Best Practices document. Medium Term Goals:

5 It was proposed that PET centres participating in PET MUSE submit one image and summary information quarterly and participate in teleconferences to discuss any quality issues. Both PET and CT parameters should be collected. Leveraging existing communication fora to engage all centres in similar QA reporting, once refined through the initial trial discussions, was discussed. This fosters a community of practice around quality for the centres, and has been successful in the past in facilitating information sharing regarding best practice. Long Term Goals: Define Standards o Imaging Technology (Minimum requirement. e.g., For Cardiac PET is sufficient; for Oncology PET/CT is required; for Neurology PET/MR is an option) o Imaging Protocols for Cardiac vs Oncology vs Neurology o Diagnostic Reference Levels for CT attenuation o Training/continuing competency for both imaging technicians and interpreting physicians reading the studies. o Timeframes/intervals for recommended testing Complete the Best Practices document o Align with current CPSO guidelines Proposed: Discuss and/or develop a peer review program for technicians and physicians. o Use current CT/MRI peer review programs as a guideline for development. o Develop both an internal and external program. Action Item: Engage PET centres involved in the PET MUSE trial and OCOG to refine Best Practices for clinical trials. Engage additional physicians for the committee. 6. PET-MR/PET-CT Equivalency: Update and Discussion Earlier this year (April 2015) the Ministry of Health requested a review into the equivalency of PET/MRI and PET/CT. The international community is still assessing the accuracy of PET/MRI compared to PET/CT and unfortunately the international registry to compare PET/MRI head to head with PET/CT was not launched. A literature review will soon be completed and PET/MRI has been added to the regular 6-month summary reports. Action Item: Literature search including the current OHIP insured and Registry indications before broadening the scope. Meeting adjourned at 3:06pm

PET Steering Committee Meeting Minutes. Wednesday, January 20 th, 2016 Time: 1:30-3:30pm

PET Steering Committee Meeting Minutes Wednesday, January 20 th, 2016 Time: 1:30-3:30pm Committee Members Present: U. Metser (Chair), R. dekemp, M. Freeman, M. Greenberg, D. Hussey, A. Singnurkar, Y. Ung