PET Steering Committee Meeting Minutes. Thursday, April 23 rd, 2015 Time: 1:30 3:30 pm

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1 PET Steering Committee Meeting Minutes Thursday, April 23 rd, 2015 Time: 1:30 3:30 pm Committee Members Present: U. Metser (Chair), M. Freeman, D. Hussey, A. Singnurkar, A. Swaminath Other Attendees: A.M. Kooiman, D. Langer, V. Mak, P. MacCrostie, R. Poon, M. Teimoortagh, J. Wang Regrets: R. Beanlands, C. Caldwell, R. DeKemp, J. Dobranowski, M. Greenberg, S. Houle, R.M. Iwanochko, K. Kingsbury, W. Pavlosky Business 1. Opening Remarks 1.1. The Agenda was approved as circulated The January and February minutes were approved as circulated Updates from the chair PET MUSE Clinical Trial (PET in the staging of muscle-invasive bladder cancer) The trial protocol has been finalized. The primary trial objective is to evaluate the impact of PET on staging. A secondary objective is to assess whether PET can identify early responders to neoadjuvant therapy prior to surgery. This aim is investigational, and has been added to leverage this patient cohort. Uptake of neoadjuvant therapy has been limited, as some urologists are concerned that optimal surgical outcomes may be compromised if patients do not respond to chemotherapy. Early indicators of response will increase confidence in offering neoadjuvant therapy. Next steps include: identifying central readers at a minimum of 3 sites across the province; completing the application for a Health Canada Clinical Trial Agreement for an FDG trial; and, submitting the application to the Ontario Cancer Research Ethics Board (OCREB). Patient accrual is anticipated to begin in mid to late fall PET Siting Report The Report has been drafted, and is in executive review at Cancer Care Ontario prior to sharing with the Ministry. Once finalized and approved, the Report will be made public. It is hoped that this Report will provide a balanced, evidence-based perspective on delivery of PET scanning services for patients in the North East. The contributions and review from all Committee members was appreciated Canadian Centre for Applied Research in Cancer Control (ARCC) Conference

2 Two abstracts will be presented by Cancer Care Ontario at the upcoming conference in Montreal, showcasing work in PET scanning in Ontario: A poster presentation regarding the development of the PET Siting model. An oral presentation on the development of the lymphoma staging registries Reviewer of Follow-up Items from Prior Meetings Epilepsy Registry update Development of the epilepsy registry is underway. The draft pre- and post-scan forms are in final stages of development; once complete they will be brought to the Committee for discussion. Currently all epilepsy PET requests go through the PET Access program. The Registry resulted from an evidentiary review (currently in preparation for submission to the Canadian Journal of Neurological Sciences), suggesting that although PET scanning may have significant impact on patient care, the current evidence base is insufficient to support a recommendation for insured services. Robust data collection through the Registry will facilitate evaluation of utility. This registry is unique for PET scanning in Ontario, as it will be the first PET registry with a neurological indication Cardiac Sub-Committee Recently the PET Access Program received a request for a PET scan to confirm if a patient had an infected aortic graft in order to determine whether or not the graft should be removed (major surgery). The panel of experts has requested guidance for future similar requests. There is conflicting literature regarding the utility of PET in inflammation of aortic/vascular grafts and in infected pace makers. It is suggested that the Cardiac Sub-Committee, in conjunction with the Cardiac Care Network, perform a formal literature review to determine whether a clinical trial or a registry would be warranted. In the interim, future cases submitted to the PET Access Program will be re-directed to the Cardiac Special Access Program at the University of Ottawa Heart Institute for review by cardiac specialists. Action Item: Literature review regarding the utility of PET in inflammation of aortic/vascular grafts and in infected pacemakers PET in Pediatrics

3 At a previous PET Steering Committee meeting there was discussion around whether or not a Clinical Trial Agreement (CTA) is required for pediatric PET scans. Health Canada has clarified that no CTA is needed for pediatric patients Pediatric Ewings Sarcoma Trial The Childrens Oncology Group (COG) has initiated a multi-centre international trial for Ewings Sarcoma patients. Imaging outcomes include assessing whether FDG-PET scanning can detect metastases, and determine treatment response and early recurrence. The study protocol includes several PET scans per patient. A local principal investigator (PI) has inquired about funding through the current Pediatric Registry. It was noted that the standard of care for pediatrics is enrollment in clinical trials. Some of the scans performed as part of the trial also already meet Pediatric Registry criteria. Funding mechanisms for the remainder through the provincial program are being considered. There is also interest in whether the imaging findings will be available to Ontario investigators to assist with decision making. Action Items: Confirm the anticipated volume of patients in Ontario; Liaise with the imaging lead to discuss options for data sharing. 2. Insured/Uninsured Program Updates 2.1. Insured Program Inquiry re: PET/MRI and Infrastructure Monitoring In response to inquiries regarding the status of PET/MRI, the Ministry requested an update regarding the use of PET/MRI (currently and in the future). PET/MRI is a relatively new technology in Canada. Currently Ontario has a single PET/MRI unit (London) with two pending (Toronto, and likely Ottawa). The international community is still assessing the accuracy of PET/MRI compared to PET/CT. PET/CT images are corrected for attenuation using the CT component; attenuation correction for PET/MRI, using MRI, is not identical. There is thus concern for errors due to mis-registration; e.g., missed bone lesions when compared to PET/CT. An international registry has been opened by the 3 largest vendors of PET/MRI comparing PET/MRI head to head with PET/CT to verify the relative accuracy of PET/MRI. It was felt that an inventory of PET/CT and PET/MRI scanners in Canada including those used for research only (versus clinical service) would be beneficial. Action Items: Inquire on the status and findings of the international registry, and whether the results are available; PET/MRI will be added to the regular 6-month

4 evidence summaries; the inventory of PET scanners will be expanded to include PET/MRI scanners, and PET/CT dedicated to research Uninsured Updates Volumes (Registry, Access) and Wait Times Cancer Care Ontario s mandate for the Evidence-Based PET program, including oversight for the PET Registry and PET Access, in April There is now 5 years worth of data available for review. The oncology PET Access Program has been steady with between scans per year. The oncology Registry volumes vary significantly depending on the current open Registries. When the program launched the following Registries were open: o o o o Esophageal Staging Pancreatic Staging Melanoma Staging Testicular Staging (combined with OHIP insured indication in 2012; very low volumes) In April 2012 the Esophageal Registry became an OHIP insured indication causing the volumes to drop significantly (from 899 in fiscal year 2011/2012 to 184 scans in fiscal year 2012/2013). In May 2013 the Lymphoma Staging Registry launched, increasing the Registry volume to 450 for the FY 2013/2014. In September of 2014, the Journal of Clinical Oncology recommended the use of PET for lymphoma staging, which has also contributed to an increase in utilization. Both the Cardiac Registry and Cardiac Access programs have been relatively stable with between scans per year combined. The majority of these cases are Cardiac Sarcoidosis, which became a Registry/Trial in The Pediatric Registry launched in April 2014 and volumes have been averaging 14 cases per month with a 79% return rate for the MD Post Scan forms. The volume of cases is consistent with what was initially projected. Lymphoma cases are the most common, with approximately 80% of cases being scanned at The Hospital for Sick Children. Wait Times The PET Steering Committee established a wait time benchmark of less than 10 business days in 2014 (i.e., 14 calendar days, 2 weeks). Currently the wait times are self-reported and the PET Centres are asked monthly at a point in time to provide their first available appointment date if a patient was to call in

5 at that moment with no restrictions, to book a PET scan. The reported wait times throughout 2014 averaged between 5-6 days, well under the established benchmark. Some centres were consistently above the provincial PET wait time average for 2014 and often above the benchmark. Cancer Care Ontario reached out to one of these centres in March to determine potential causes, and whether corrective action was planned. This centre has increased their operation to 5 days/week (from 3 days/week in 2013), 7 patients/day (hours of operation 8am-4pm). Two of the daily spots are reserved for urgent cases, but are released 48 hours prior for non-urgent bookings. This PET Centre also has some research obligations, although the volume of research scans is minimal. The PET Centre has instituted these changes within the previous 6 months and there has been improvement in their wait times. Cancer Care Ontario will continue to monitor this PET Centres wait times and work with them to ensure they are within the benchmark of 10 business days. Action Item: Continue monitoring wait times at all centres and follow-up with the PET Centres that are consistently above the benchmark to work with them to meet the provincial benchmark Access Reviewer Turnaround Times The PET Access program currently employs two panels of experts (3 experts/panel). These panels have been with the program from its inception at the Ministry of Health and continued on when Cancer Care Ontario assumed operations of PET Access in The approval rates between the two panels are similar, around 73%. The PET Access program policy states the expert panels have up to 5 business days to respond to a case. However, expert panel response time has typically averaged less than 2 business days. The volume of PET Access cases for review has increased over the past 5 years and Cancer Care Ontario is currently in the process of recruiting a third panel of experts. The Expression of Interest closed on April 15 th, 2015 and they have received a few applications. Action Item: Applications for additional PET Access Expert Panel members will be reviewed and a third panel recruited. 3. Clinical Case 15 year old male with Burkitt s lymphoma was previously staged with the standard staging workup including CT, Bone scan, and Gallium scan. The Gallium scan showed disease in the left neck area only. Nothing was seen on CT or on the Bone scan. Based on the standard staging work-up the patient had stage I disease with only one area of involvement.

6 A PET scan was requested to complete the staging of the patient. PET scan results showed additional uptake in the left femur, pelvis and lumbar spine, upstaging the patient to stage IV. The patient received much more aggressive treatment due to the PET scan results. The patient is completely healthy now and being followed by clinic, 4 years later. 4. Melanoma Recommendation The Melanoma Registry includes the following two indications: Staging of melanoma patients with localized high risk tumours with potentially resectable disease; Evaluation of patients with melanoma and isolated metastases at the time of recurrence when metastasectomy is being contemplated Analysis of this Registry was performed to assess the utility of PET in staging advanced or high-risk melanoma as a useful adjunct to clinical and standard radiologic investigation. Between January 2011 and July 2013, 319 melanoma patients received PET scans. The pre-pet stage information was provided by the referring clinician and was compared to the post-pet stage. The Registry data was then linked to provincial administrative databases. The results of the analysis showed a significant increase in stage from M0 to M1 after PET in 17.6% of patients. There is also a significant relationship between upstaging with PET and the proportion of patients undergoing surgical resection of metastases distant to the primary melanoma. There was no significant relationship between upstaging with PET and radiation or systemic therapies, although it was noted that the administrative datasets are limited in their ability to capture direct changes to planned radiation or systemic treatments. Recommend a refinement in the wording of the original PET Registry indications when submitting the indication to the Ministry for an OHIP insured indication (which was also supported by the Disease Site Group): The use of PET for melanoma in the setting of localized high-risk melanoma, or under consideration for metastasectomy While the Ministry package is prepared, and pending Ministry decision on funding, patients will continue to access PET scans for these indications through the PET Registry. Action Item: Prepare a package for the Ministry to recommend the use of PET scanning for localized high-risk melanoma as an OHIP insured indication 5. Registries Analysis 5.1. Pancreatic Registry

7 As of December 2014 there are over 200 patients accrued in the pancreatic cancer staging Registry. A recommendation has been made to initiate data analysis on the utility of PET scanning in this scenario. The Registry was initially designed with minimal data collection. To maximize the Committee s ability to assess impact of the PET scan, an additional review of the PET scan report is planned. As per other Registry analyses, this information would then be linked to administrative databases to facilitate assessment of the PET scan on patient management. Action Item: Original PET scan reports for pancreatic registry patients will be collated and reassessed Lymphoma Staging Registry The Lymphoma Staging Registry launched in May 2013 with the following 2 indications: PET for the staging of Hodgkin s or non-hodgkin s lymphoma being treated with curative intent for the staging of limited disease as per conventional imaging or when imaging is equivocal for differentiating between limited and advanced stage disease. PET for apparent limited stage nodal follicular lymphoma or other indolent non- Hodgkin s lymphomas where curative radiation therapy is being considered for treatment There are 593 patients in the database as of March 2015, averaging 26 cases per month, with an overall 74% return rate for the MD Post Scan forms. In September 2014 the Lugano classification system was published in the Journal of Clinical Oncology, recommending PET/CT scanning as part of the staging work-up. The PET Steering Committee agrees there are enough patients to begin analysis of the data to support a recommendation for the addition of these indications to the insured program (pending results of the analysis). Analysis will include Registry patients accrued to the end of May, 2015, which will represent two years of data. Action Item: Commence analysis of lymphoma registries, including patients who received scans between May 2013 May A working group including referring and imaging physicians will be formed to assist in the clinical aspects of analysis. 6. Emerging Areas 6.1. Anal Canal cancer The PET Steering Committee has received from the Gastro-intestinal Disease Site Group (GI DSG) a request to review evidence regarding the routine use of PET scans in the staging of anal canal cancer. Action item: Perform an evidentiary review; ask the GI DSG to provide the literature they have found

8 6.2. Sarcoma There have been inquiries as to the status/evidence surrounding the use of PET in sarcoma, and potentially streamlining access. Currently, some sarcoma studies have been identified in the 6- mo monitoring reports; however, evidence has been limited. Action Item: The requestor will be contacted to clarify their request, and request their participation as part of an evidentiary review, if warranted. 7. Cancer System Quality Index (CSQI) PET Indicators The Cancer System Quality Index is an annual report which will be publicly published on May 20 th, 2015 for the 2013 year. This year the report will include PET specific indicators regarding utilization and wait times. In PET/CT scans were completed per million population in Ontario. This is comparable to the volume of scans completed in 2012, however there continues to be significant regional variation across Ontario. This variation is likely driven by differences in physician referral patterns and their awareness of the PET/CT program. Cancer Care Ontario (CCO) has developed aims for PET/CT utilization across the province for both the Non-small cell lung cancer (NSCLC) insured indication and the lymphoma insured indications. CCO developed these aims with the relevant DSGs. This is new for this year. The CCO aim for NSCLC utilization is between 45-50%. While most LHINs fall somewhere close to or within the aim, the NW LHIN falls significantly below the aim and the Champlain LHIN is significantly above. There is some initial work to assess whether there may be data quality issues impacting the indicator(s). The CCO aim for post treatment lymphoma utilization is 50-75%. The provincial utilization rate falls significantly below this aim and is around 20% and there is concern this aim is too high. This data is from 2013 and as the lymphoma staging registry only launched mid-way through 2013 it is possible that more patients are being referred in 2014 onwards for post treatment lymphoma as well. Will be revisiting the data for For mid-treatment Hodgkin s Lymphoma the CCO aim is 25-40% and provincial utilization is slightly higher than the aim. As lymphoma volumes are significantly lower than those for lung indications, the indicator(s) were presented at a provincial level to avoid issues related to small volume size. For both the lung and lymphoma indications there is a concern of data quality and coding correctly when billing to the Ministry through OHIP. CCO will be reaching out to the LHINs to improve coding accuracy going forward. Wait times in this report can be defined as the date from when a patient has been confirmed to meet the indication to the date of the first available appointment.

9 The CSQI messaging regarding wait times is that they have remained consistent, significantly below the benchmark of 10 business days, the median around 5-6 business days, despite a dramatic increase in PET scan volumes between 2010 and This shows the system capacity can manage changes in volume. It is important to note utilization is not tied to regions with PET Centres. Patients are able to get their PET scans regardless of where they live in Ontario. Recommendations for data to be included in next year s CSQI annual report include utilization rates for the Lymphoma Registry indications as well as looking at turnaround time from date the request is received until the date of a PET scan. Action Item: Determine CSQI indicators for next year s report; develop physician educational material regarding the PET Scans Ontario Program and the process for submitting PET scan requests (for OHIP insured and Registry indications, as well as for the PET Access Program). Meeting adjourned at 3:42pm