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F-Fluciclovine PET/MR Scan for Brain Cancer
Phase 3
Recruiting
Led By Michael Veronesi, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a brain metastasis diagnosis with at least one single visible contrast enhancing metastatic lesion on brain MRI
Currently receiving at least one immune checkpoint inhibitor for treatment of the malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights
Study Summary
This trial will use new imaging tech to see if it can better detect cancer in people with brain metastases. Participants will have two scans over 3 hours.
Who is the study for?
This trial is for adults over 18 with brain metastasis who are currently on immune checkpoint inhibitors. They must have had a visible lesion on a recent MRI and be able to lie still for imaging. Pregnant individuals, those unable to consent, or with allergies to the tracer or contraindications for PET/MRI cannot participate.Check my eligibility
What is being tested?
The study tests whether PET/MRI scans using an F-Fluciclovine radiotracer can better detect cancerous tissue in the brain compared to other imaging methods. Participants will undergo one combined PET/MRI scan and a separate MRI scan during about three hours of study participation.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the F-Fluciclovine radiotracer or discomfort from lying still during the scanning process. The specifics of any additional side effects related to this tracer aren't detailed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a brain tumor that can be seen on an MRI.
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I am currently being treated with a drug that boosts my immune system to fight cancer.
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I am 18 years old or older.
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I am willing and able to have a PET/MRI scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amino acid uptake into tumor tissue
Cystolic protein in tumor cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET-MRIExperimental Treatment1 Intervention
Participants will undergo F-Fluciclovine PET radiotracer and MRI
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,501 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,957 Total Patients Enrolled
Michael Veronesi, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is fusion imaging in PET-MRI compliant with FDA regulations?
"The team at Power gives PET-MRI a safety rating of 3, based on the amount of efficacy and safety data gathered from Phase 3 trials."
Answered by AI
Are there current opportunities to enroll in this research effort?
"Records retrieved from clinicaltrials.gov show that, though initially listed on December 1st 2023 and last updated November 28th of the same year, this trial is not currently searching for participants. Nevertheless, there are 921 other medical studies open to new enrollees at present."
Answered by AI
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