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

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1 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 Other Attendees: M. Filion, C. Bedford, A.M. Kooiman, D. Langer, P. MacCrostie, V. Mak, S. Metcalfe, R. Poon, J. Wang, Regrets: R. Beanlands, G. Clarke, J. Dobranowski, K. Kingsbury, A. Swaminath Business 1. Opening Remarks 1.1. The Agenda was approved as circulated The December minutes were approved as circulated Updates and follow-up items A request for an update on the status of the July 2013 recommendation to add Rubidium-82 PET (Rb-PET) for myocardial perfusion imaging as an insured service was submitted to the Ministry Volume-related funding pressures experienced by the PET centres in relation to provision of insured services were communicated to the Ministry Approval has been given to proceed with development and launch of a trial to assess the role of PET in advanced breast cancer. 2. PET MUSE (PET in muscle-invasive bladder cancer) Status Update Preparation to open the PET MUSE trial to patient recruitment is in final stages: the case report forms have been finalized; the database is up and running, and; the central review process (secondreads of the images) has been finalized. Sunnybrook is scheduled to be the first site activated by the end of January 2016 with the Juravinski site soon to follow. Patient accrual will start soon after. Quality Assurance (QA) processes for participating PET centres were discussed. Two documents were presented, to be completed by each site. The first provides documentation on the PET scanner being used for the study and includes basic information as well as details of accreditation, if relevant. To provide a baseline for scanner performance, scans of a standardized object ( phantom ) will need to be completed.

2 The second document is to be completed at regular intervals throughout the trial to confirm the quality of the images remains the same as at the beginning of the trial. There was discussion around who should complete this form, and how often it should be completed. It was noted that QA for previous provincial PET trials included submission of a clinical case, monthly, from each site. It may be feasible to leverage the central read process and/or image storage for this trial; all images are anonymized, but amendment of patient consent forms is also likely in order to reflect this additional use. Tools and processes to support high quality trials were discussed, including connecting study sites regularly via teleconference to discuss QA issues. The overall meeting frequency of the PET centres for these meetings was discussed; early provincial trials had centres meeting monthly as the technique(s) were new, but this was relaxed to quarterly after years of operation. Additionally, it was felt that development of Standard Operating Procedures (SOPs) and workflow document would be beneficial. Action Item: Develop the QA SOPs for phasing in the study. Include a workflow. Action Item: Distribute the equipment form to all sites prior to activation. 3. PET/MR vs PET/CT In response to an inquiry, the Ministry had previously asked whether the performance of combined PET and MRI (PET/MR) is comparable to the current standard of care for PET imaging combined PET and CT (PET/CT), primarily in the diagnosis and staging of patients with cancer. It was noted that PET/MR is performed clinically in the United States and some parts of Europe; however, it is not clear how it is funded (e.g., PET and MR may be reimbursed separately, not necessarily as one scan). To inform whether it would be appropriate to support PET/MR as (at least) an equivalent to PET/CT, a literature review was performed with a focus on the insured oncology indications. The systematic review was challenging as the literature was not necessarily limited to indications that are covered by OHIP. It was also unclear as to whether results assessed equivalency of the PET component (corrected by CT or MR), or whether the additional diagnostic capabilities of the MR versus CT were also considered, confounding direct comparison. The review included all studies up to July 2015, with a minimum of 12 patients, a full peer review article, and evaluated the use of PET/MR and PET/CT with FDG and integrated MR. Over 7000 unique citations were found, but only 12 studies (7 prospective and 5 retrospective) were relevant. Of these 12 studies the disease sites covered were breast cancer (2), esophageal cancer (1), gynecologic cancer (1), head and neck cancer (1), non-small cell lung cancer (2), and various sites (5). The literature review did not provide enough evidence to confirm PET/MR can be used interchangeably with PET/CT. The outcome from the systematic review is that further data analysis is required.

3 Discussion centered around two study options: Comparing the sensitivity and specificity of PET/MR vs PET/CT on individual patients, requiring patients to have both PET/MR and PET/CT on separate occasions so that timing between injection of FDG and the scan is not a factor. However, this would require a patient to receive a radiopharmaceutical twice, as well as requiring two visits. Compare stage and age matched cohorts. For example, the percentage of patients with non-small cell lung cancer that are upstaged with PET/CT is known, and could be compared to a similar cohort of patients who have had a PET/MR. If the patients who had a PET/MR showed similar (or better) rates of upstaging, this would suggest equivalence of PET/MR and PET/CT for the non-small cell lung cancer indication. The ability to generalize results across indications was also discussed e.g., what level of evidence would be required, individually, for each indication, and what could be inferred across some scenarios. Information content and requirements for each indication (e.g., cardiac) also need be considered. Additionally, there is emerging literature surrounding the cognitive impact of recurrent sedation in the pediatric population. As MRI requires more frequent and intense sedation this will need to be considered when determining equivalency of PET/MR with PET/CT in pediatrics. Action Item: The evidentiary summary will be submitted for publication; a working group of PET Steering members will consider how best to address gaps in evidence to inform recommendations of equivalency. 4. CSQI 2016 PET Indicators This will be the third year PET indicators have been publicly reported as part of the Cancer System Quality Index (CSQI). Historically the CSQI report has included PET utilization by LHIN of patient residence, PET utilization in non-small cell lung cancer, PET utilization for lymphoma treatment assessment, (all volumes normalized by overall population or disease incidence, as relevant), and wait times Different burden of disease by region has meant that reporting PET utilization per population has caused some confusion in the regions; thus, although PET scanning is not appropriate for all cancers, it was felt that moving to normalization by cancer incidence would better reflect differences in utilization rates between LHINs on the upcoming report. For PET in non-small cell lung cancer, challenges identified with the current approach are the difficulties in defining an appropriate target rate due to multi-layered assumptions as well as inconsistent coding of the scans. The rate also does not necessarily relate to the impact of the scan for patients. For 2016, CSQI will report on the percentage of non-small cell lung cancer (NSCLC) patients who received a PET scan prior to lung resection. This is reflective of appropriate practice close to 100% of patients should have received a PET scan prior to surgery.

4 The limitation of the updated indicator is that it will only include patients who have had a lung resection, and does not include patients who had a PET scan and were upstaged to stage IV and became ineligible for surgery, or patients who received other therapies (e.g., radiation) with curative intent. Looking forward to the 2017 CSQI report, this approach could be expanded to other similar indications (e.g., small cell lung cancer and esophageal cancer) which would also have a target rate close to 100%. For lymphoma, the current CSQI report (2015) included the insured indications at a provincial level. Similar to the lung cancer indicator, there were challenges in identifying an appropriate target, as well as some data quality issues related to variation in how the scans were entered by PET centres. For the 2015 report, the lymphoma staging registry had not yet been open for accrual for a full year. For 2016, the CSQI indicator will focus on the lymphoma staging Registry utilization of PET for the staging of aggressive lymphoma being treated with curative intent. This will provide a good baseline measurement, as the data being presented in the 2016 report is from the first full year of the registry being open (2014), and is prior to the Journal of Clinical Oncology (JCO) guidelines recommending PET for staging of lymphoma. Data will be presented at a provincial level for this first year, and include note that an increase in utilization is underway due to the JCO publication. The final indicator in the CSQI report is the reported wait time between patient referral and scan (a point-in-time measurement, monthly, reported by PET centres). The target wait time is ten business days and, overall, the median wait time is below this target. Historically, PET centres with the highest wait times shifted from month to month. However, over time some centres are more consistently on the high end in the province due to increased volume pressures on a regular basis. There are no planned changes to this indicator, but the language in the write up will be amended to reflect these trends. 5. Insured/Uninsured Program Updates 5.1. Q2 report (Program Summary) Cancer Care Ontario assumed management of the uninsured PET program in May 2010 and the quarterly volumes from May 2010 to September 2015 were presented for both the insured and uninsured programs. Overall the insured volumes have doubled in the previous 5 years and the uninsured volumes have remained relatively consistent. It was noted that some uninsured indications (e.g., esophageal) moved to insured services over this timeframe. The Pancreatic Registry currently has 219 scans and is in the early stages of data analysis. As 82% of all scans were completed at a single PET centre, local analysis is being explored. Results would be brought to an upcoming PET Steering Committee meeting. The Melanoma Registry has over 1000 scans and a recommendation report is being prepared for the Ministry to have this indication included in the next schedule of benefits.

5 The Lymphoma Staging Registry has just under 1000 scans and the data analysis has begun. This was the first Registry that had a physician post scan form component. The current return rate for the physician post scan form is 72% overall and has dropped significantly since November Once the data analysis has been completed it is hoped submission can be simplified, and the requirement for physician post scan forms can be lifted. The Pediatric Registry has consistent volumes around 42 scans/quarter with a physician post scan return rate of 82% overall. Currently there are approximately 250 scans in the database Epilepsy Registry Launch The Epilepsy Registry is ready to launch on February 1 st, The communication plan is being finalized. Information will be disseminated through the Epilepsy Centres of Excellence as well as the PET centres providing the scans PET Steering Membership Deferred to a future meeting Meeting adjourned at 3:38pm