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Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine for Brain Tumor

Phase 2
Recruiting
Led By John Hoffman, MD
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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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...
My recent lab tests are within the required range for the imaging procedure.
Select...
I am 18 years old or older.

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
Increased Overall Survival
Secondary outcome measures
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

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
1,089 Previous Clinical Trials
1,728,355 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,987 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

Frequently Asked Questions

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

What is the total number of participants in this clinical research experiment?

"Affirmative. Records present on clinicaltrials.gov demonstrate that this medical trial is currently enlisting individuals; it was initially advertised in September 24th 2018, and the details were most recently updated October 6th 2022. The study demands 30 participants from a single location."

Answered by AI

Are any new participants still eligible for this investigation?

"Yes, the current data on clinicaltrials.gov shows that this experiment is actively recruiting participants. It was initially posted in September 2018 and revised most recently in October 2022, with a need for 30 individuals across one medical centre."

Answered by AI

Are there any records of experiments in which the imaging techniques [18F]FLT and [18F]Fluciclovine have been utilized together?

"At the moment, 4 active clinical trials are researching Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine with zero currently in Phase 3. These studies have been established across three different locations, one of which is Pittsburgh, Pennsylvania."

Answered by AI

Is this the inaugural iteration of this particular clinical research?

"Since 2018, Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine have been investigated by Blue Earth Diagnostics. After the initial study with 30 participants in 2018, Phase 2 drug approval was granted for this product. Currently, there are 4 active studies on this topic taking place across 3 cities and 1 country."

Answered by AI

Has the US Food and Drug Administration granted approval for Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine?

"Considering the lack of data validating its efficacy, Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine have been assigned a score of 2 on Power's safety scale."

Answered by AI
~5 spots leftby Mar 2025