PET Imaging for Neuroendocrine Cancer

Overseen By Patrick Veit-Haibach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Lung neuroendocrine tumors, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug F18-FDG, Fluorodeoxyglucose F 18, FDG-PET for neuroendocrine cancer?

Research shows that FDG-PET can help identify patients with more aggressive neuroendocrine tumors and predict survival, which suggests it may be useful in managing these cancers. ^{1 2 3 4 5}

Is PET imaging with F18-FDG safe for humans?

PET imaging with F18-FDG has been widely used in oncology and is generally considered safe for humans. It involves a small amount of radioactive material, but the exposure is low and typically well-tolerated. ^{2 6 7 8 9}

How does PET imaging differ from other treatments for neuroendocrine cancer?

PET imaging, particularly using tracers like Gallium-68, is unique because it can detect small-volume disease and skeletal metastases more effectively than traditional imaging methods. This makes it especially useful for identifying aggressive forms of neuroendocrine tumors that might not be visible with other techniques. ^{1 2 3 6 10}

Research Team

Ur Metser, MD

Principal Investigator

University Health Network, Toronto

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo dual-tracer PET imaging using 68Ga-DOTATATE and 18F-FDG to assess tracer uptake and tumor characteristics

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in clinical management and tumor characteristics based on imaging results

2 years

Treatment Details

Interventions

• F18-FDG

Trial Overview The 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

Group I: 18F-FDG PETCT scan Experimental Treatment 1 Intervention

18F-FDG tracer (5 MBq/kg body weight of FDG; up to 550 MBq) will be injected into the intravenous

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Neuroendocrine Tumour Society (CNETS)

Collaborator

Trials

1

Recruited

40+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical Usefulness of 18F-Fluorodeoxyglucose Positron Emission Tomography in the Diagnostic Algorithm of Advanced Entero-Pancreatic Neuroendocrine Neoplasms. [2019]

2. Austria pubmed.ncbi.nlm.nih.gov

Monitoring the efficacy of iodine-131-MIBG therapy using fluorine-18-FDG-PET. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

18F-fluorodeoxyglucose positron emission tomography predicts survival of patients with neuroendocrine tumors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

High prognostic value of 18F-FDG PET for metastatic gastroenteropancreatic neuroendocrine tumors: a long-term evaluation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Role of 18FDG PET/CT in patients treated with 177Lu-DOTATATE for advanced differentiated neuroendocrine tumours. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography (PET) in diagnostics of gastroenteropancreatic neuroendocrine tumours (GEP NET). [2015]

7. United States pubmed.ncbi.nlm.nih.gov

68Gallium-DOTATATE positron emission tomography-computed tomography (PET CT) changes management in a majority of patients with neuroendocrine tumors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of 18F-AlF-NOTA-Octreotide PET/CT in Combination With 18F-FDG PET/CT for Imaging Neuroendocrine Neoplasms. [2019]

9. Norway pubmed.ncbi.nlm.nih.gov

[Positron emission tomography in neuroendocrine tumours]. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Combination of cross-sectional and molecular imaging studies in the localization of gastroenteropancreatic neuroendocrine tumors. [2022]