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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
Treatment naïve patients and/or patient who have received any number of prior systemic therapy lines for metastatic disease and/or locally advanced inoperable tumor
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have not been treated or have been treated for advanced cancer.
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My tumor is growing or dividing quickly.
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I am 18 years old or older.
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I have had or am scheduled for a 68Ga-DOTATATE PET/CT scan.
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I have a confirmed neuroendocrine tumor in my digestive system.
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My tumor is classified as Grade 2-3, indicating a moderate to high level of abnormality.

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

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

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT01146054
29%
Lymphocyte count decreased
29%
Anemia
27%
Anorexia
27%
Fatigue
24%
Abdominal Pain
12%
Nausea
10%
Platelet Count Decreased
8%
Dyspepsia
6%
Constipation
2%
Duodenal hemorrhage
2%
Duodenal Ulcer
2%
Dehydration
2%
Sepsis
2%
Duodenal Fistula
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT and Gemzar

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?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,759 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for individuals to join the experiment?

"Based on the information provided by clinicaltrials.gov, this study is still enrolling patients as of May 20th 2022. The trial was initially launched in March 4th 2021."

Answered by AI

What other investigations have been conducted surrounding this therapy?

"Currently, 18 studies are being conducted in relation to this treatment. One is at the pivotal Phase 3 stage and 19 different sites across Wuhan, Hubei province are running tests on it."

Answered by AI

What conditions can this particular remedy ameliorate?

"This pharmaceutical is typically used to manage seizures, but it has also been demonstrated as a viable option for treating coronary artery disease (CAD), cancer, and positron emission tomography."

Answered by AI

What is the current enrollment of this clinical research endeavor?

"Affirmative. According to clinicaltrials.gov, this research is actively enrolling participants; it was first published on March 4th 2021 and the most recent update occurred on May 20th 2022. The study requires 40 individuals from one medical site."

Answered by AI
~10 spots leftby Mar 2025