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PET Imaging for Neuroendocrine Cancer

N/A
Waitlist Available
Led By Ur Metser, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a tumour with a proliferation index (Ki67 ≥3%) or in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index ≥2 mitosis/10HPF (high power fields)
Patients who already had/scheduled for a 68Ga-DOTATATE PET/CT scan
Must not have
Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible
Mixed neuroendocrine and non-neuroendocrine cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine if a correlation exists between how a tumor looks on a DT PET scan and how aggressive it is.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions at the injection site for tracers used in PET scans such as pain or swelling, allergic reactions to tracers which could range from mild itching to more severe responses like difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is growing or dividing quickly.
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I have had or am scheduled for a 68Ga-DOTATATE PET/CT scan.
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My tumor is classified as Grade 2-3, indicating a moderate to high level of abnormality.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is not a lung neuroendocrine tumor or related to non-digestive system cancers.
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My cancer is a mix of neuroendocrine and non-neuroendocrine types.
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My tumor is a Grade 1 neuroendocrine tumor.
Select...
My cancer is a type of aggressive neuroendocrine tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Discordance in tracer uptake
Impact to patient management
Secondary study objectives
Intraindividual tumor heterogeneity
Tumor texture features as predictors of tumor metabolism and somatostatin receptor expression
Tumor texture geatures as predictors of tumor grade

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Canadian Neuroendocrine Tumour Society (CNETS)UNKNOWN
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,158 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
2,646 Patients Enrolled for Neuroendocrine Tumors
Ur Metser, MDPrincipal InvestigatorUniversity Health Network, Toronto
6 Previous Clinical Trials
739 Total Patients Enrolled

Media Library

18F-FDG PETCT scan Clinical Trial Eligibility Overview. Trial Name: NCT04804371 — N/A
Neuroendocrine Tumors Research Study Groups: 18F-FDG PETCT scan
Neuroendocrine Tumors Clinical Trial 2023: 18F-FDG PETCT scan Highlights & Side Effects. Trial Name: NCT04804371 — N/A
18F-FDG PETCT scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804371 — N/A
~3 spots leftby Feb 2025
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