~8 spots leftby Apr 2026

PET Imaging for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)
Overseen byUr Metser, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University Health Network, Toronto
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The variable clinical outcome of patients with G2 \& G3 well diff GEP-NETs makes the selection of an optimal treatment strategy challenging. Initial data suggests that high DOTATATE uptake and low FDG uptake are suggestive of low grade disease, with an indolent course. Conversely, low DT uptake and high FDG uptake are suggestive of high-grade/ aggressive disease. G2/3 GEP NETs may be biologically diverse; clinically relevant cohort for dual-tracer PET imaging. Our secondary objectives are 1. To determine the distribution of PETNET scores derived from 18F-FDG \& 68Ga-DT PET in patients with G2 \& G3 well diff GEP-NETs. 2. To determine the proportion of patients in whom the addition of 18F-FDG PET data results in a change in planned clinical management. To assess intra-individual variability in SSTR expression \& glucose metabolism (as seen on DT and FDG PET) across different tumor sites within the same patient. 2) To determine whether a correlation exists between tumor texture features on 68Ga-DT \& FDG PET to tumor grade and Ki 67 index. 3) To assess for an association between tumor texture features on 68Ga-DT PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and SSTR expression.

Eligibility Criteria

This trial is for adults with G2 or G3 well-differentiated gastroenteropancreatic neuroendocrine tumors. It's open to those who are treatment-naïve or have had previous treatments, provided they meet certain criteria like having a specific tumor grade and proliferation index. Pregnant women, patients with lung neuroendocrine tumors, Grade 1 tumors, poorly differentiated carcinomas, mixed cancers, or mental conditions affecting study comprehension are excluded.

Inclusion Criteria

My tumor is growing or dividing quickly.
I have a confirmed neuroendocrine tumor in my digestive system.
I have not been treated or have been treated for advanced cancer.
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Exclusion Criteria

My cancer is a mix of neuroendocrine and non-neuroendocrine types.
My cancer is not a lung neuroendocrine tumor or related to non-digestive system cancers.
Any patient who is pregnant
See 4 more

Treatment Details

Interventions

  • F18-FDG (Radiopharmaceutical)
Trial OverviewThe trial is studying the use of dual-tracer PET imaging using two substances (68Ga-DOTATATE and 18F-FDG) to differentiate between low-grade indolent and high-grade aggressive neuroendocrine tumors. The goal is to see if this imaging can guide treatment decisions and assess variability in tumor characteristics within the same patient.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 18F-FDG PETCT scanExperimental Treatment1 Intervention
18F-FDG tracer (5 MBq/kg body weight of FDG; up to 550 MBq) will be injected into the intravenous

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?

University Health Network, TorontoLead Sponsor
Canadian Neuroendocrine Tumour Society (CNETS)Collaborator

References