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Multi-tracer PET Imaging for Brain Tumors

Phase 2
Recruiting
Led By Jeffrey Yap, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.
Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with biopsy or surgery.
Must not have
Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
Adult patients who require monitored anesthesia for PET scanning.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether two PET imaging agents can better predict tumor response and overall survival than MRI in patients with high-grade brain tumors.

Who is the study for?
This trial is for adults with high-grade primary brain tumors who are undergoing or have completed chemoradiation. It includes those with inoperable tumors, confirmed diagnoses via MRI/CT scans, and possible tumor recurrence. Participants must be willing to follow up for 24 months and provide consent. Pregnant women, HIV positive individuals, patients under 18, or those too claustrophobic for PET scans are excluded.
What is being tested?
The trial tests if [18F]Fluciclovine and [18F]FLT PET/CT imaging can better predict the response of high-grade brain tumors to treatment compared to standard MRI criteria. The goal is to improve assessment of tumor aggressiveness and differentiate between actual tumor progression and treatment effects.
What are the potential side effects?
While specific side effects aren't listed for the PET agents being tested ([18F]Fluciclovine and [18F]FLT), potential risks may include allergic reactions similar to other radiopharmaceuticals used in PET scanning procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor cannot be removed surgically, so I had a biopsy instead.
Select...
My scans suggest I have a high-grade brain tumor, awaiting confirmation.
Select...
I have a high-grade brain tumor and will get chemoradiation. My surgery didn’t remove all of it, leaving a part larger than 1 cm.
Select...
I have a high-grade brain tumor and might have a recurrence or treatment side effect within 6 months after chemoradiation.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe brain symptoms like sudden pupil changes, quick muscle weakness, or fast drops in alertness.
Select...
I need anesthesia for PET scans.

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
Increased Overall Survival
Secondary study objectives
Ability of [18F]FLT and/or [18F]Fluciclovine alone or together to predict true progression from pseudoprogression
Association between overall survival and quantitative markers
Association between progression free survival and quantitative markers
+2 more

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: All Enrolled participantsExperimental Treatment1 Intervention
Multi-tracer PET exams of \[18F\]FLT and \[18F\]Fluciclovine

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,611 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
41 Previous Clinical Trials
3,052 Total Patients Enrolled
Jeffrey Yap, PhDPrincipal InvestigatorUniversity of Utah
5 Previous Clinical Trials
75 Total Patients Enrolled
John Hoffman, MDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine Clinical Trial Eligibility Overview. Trial Name: NCT03276676 — Phase 2
Brain Tumor Research Study Groups: All Enrolled participants
Brain Tumor Clinical Trial 2023: Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine Highlights & Side Effects. Trial Name: NCT03276676 — Phase 2
Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03276676 — Phase 2
~1 spots leftby Dec 2025
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