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FET-PET Imaging for Brain Tumor Detection (UC-GlioFET Trial)

Phase 2

Waitlist Available

Led By Thomas A Hope, MD

Research Sponsored by Thomas Hope

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 3 years

Presence or suspicion of intracranial neoplasm in two populations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

UC-GlioFET Trial Summary

This trial uses an imaging agent to see if it can help detect tumors in participants who have had them come back.

Who is the study for?

This trial is for people over 3 years old with brain tumors that might have returned after treatment. It includes those who've had surgery or radiation and show signs of recurrence on MRI, covering both high-grade (more serious) and low-grade tumors.Check my eligibility

What is being tested?

The study tests how well a substance called F-18 Fluoroethyltyrosine (FET) can help identify recurring brain tumors using PET scans. FET highlights cancer cells in the brain, which could improve tumor detection and assessment.See study design

What are the potential side effects?

There are no direct side effects mentioned for F-18 Fluoroethyltyrosine as it's used for imaging purposes. However, general risks may include allergic reactions to the tracer or discomfort from lying still during the PET scan.

UC-GlioFET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 3 years.

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I might have a brain tumor.

UC-GlioFET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1)

Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)

Secondary outcome measures

Binary characterization of follow-up imaging as positive/negative for tumor recurrence

Degree of inter-rater reliability for radiological interpretations

Degree of inter-rater reliability for tracer uptake

+1 more

UC-GlioFET Trial Design

2Treatment groups

Experimental Treatment

Group I: Population 2: Suspected glial neoplasmsExperimental Treatment2 Interventions

Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Group II: Population 1: Intracranial neoplasms (glial or metastatic disease)Experimental Treatment2 Interventions

Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1390

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas HopeLead Sponsor

9 Previous Clinical Trials

1,465 Total Patients Enrolled

Thomas A Hope, MDPrincipal InvestigatorUniversity of California, San Francisco

3 Previous Clinical Trials

384 Total Patients Enrolled

Media Library

F-18 Fluoroethyltyrosine (FET) Clinical Trial Eligibility Overview. Trial Name: NCT04044937 — Phase 2

Gliomas Research Study Groups: Population 2: Suspected glial neoplasms, Population 1: Intracranial neoplasms (glial or metastatic disease)

Gliomas Clinical Trial 2023: F-18 Fluoroethyltyrosine (FET) Highlights & Side Effects. Trial Name: NCT04044937 — Phase 2

F-18 Fluoroethyltyrosine (FET) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044937 — Phase 2

Frequently Asked Questions

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

Is this medical research accepting new participants?

"Per the information available on clinicaltrials.gov, this medical research is presently looking for participants. It has been active since October 29th of 2018 with its latest update occurring November 7th 2022."

Answered by AI

Is F-18 Fluoroethyltyrosine (FET) a reliable treatment option with minimal risks?

"Our team's assessment of F-18 Fluoroethyltyrosine (FET) safety is a 2, as there exists some data indicating its security but it has not yet been tested for efficacy."

Answered by AI

In what clinical contexts is F-18 Fluoroethyltyrosine (FET) typically prescribed?

"The symptoms of amino acid supplementation, acute coryza, and amino acid supplementation therapy can be alleviated by administering F-18 Fluoroethyltyrosine (FET)."

Answered by AI

How many people have enrolled in this medical experiment thus far?

"Confirmed. According to the information published on clinicaltrials.gov, this trial is actively enrolling individuals and has been since October 29th 2018 (most recently edited November 7th 2022). The study's authors hope to recruit 199 people from a single medical centre."

Answered by AI

Is this research a pioneering endeavor or has it been conducted before?

"At present, there are 55 ongoing trials for F-18 Fluoroethyltyrosine (FET) occuring in 1094 cities and 14 countries. The initial study of its kind was conducted by Baxter Healthcare Corporation back in 2007 with 4640 participants, eventually attaining Phase 4 drug approval status. Since then, 58 studies have been carried out on this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

Thomas Hope 2018. "Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04044937.

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