18F-FLUC PET/MR in Patients With Brain Mets

Recruiting now · Phase 3

Conditions studied: Brain Metastasis, Radiation Therapy, Immunotherapy, Active

In brief

The goal of this clinical trial is to use new imaging methods to help in finding out whether the imaging shows that there is a tumor in people with a brain metastasis. The main question it aims to answer is whether positron emission tomography (PET) and magnetic resonance imaging (MRI) find cancerous tissue better than other types of imagining. Participants will undergo a single PET/MRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.

Key facts

Study ID

NCT06159335

Run by

University of Wisconsin, Madison

People needed

30

Starts

2024-01-10

Expected to finish

2027-06-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Able and willing to provide informed consent
• Has a brain metastasis diagnosis with at least one single visible contrast enhancing metastatic lesion on brain MRI
• Received radiation therapy at some point in the last 2 years
• Is currently being treated with or has been treated with any other concurrent systemic therapy (multi-modal therapy) in the past 6 months, which would include immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or chemotherapy following radiation therapy.
• Patients are eligible for the study if their most recent standard-of-care MRI, used to assess disease location and extent, raises the question of tumor recurrence versus treatment-related changes. This concern can be noted by the radiologist or other members of the multidisciplinary care team, such as during a multidisciplinary conference. Additionally, if there are clinical concerns based on evolving exam findings or symptoms, and the treating physician suspects progression versus treatment-induced changes, the patient is also eligible for the study.
• Be able to lie still for 30-60 minutes during the imaging procedure
• Willing and able to undergo PET/MRI or PET/CT
• Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
• The subject has their own prescription for the medication
• The informed consent process is conducted prior to the self-administration of this medication
• They come to the research visit with a driver

You may not qualify if…

• Subject unable or unwilling to provide informed consent
• Subject is pregnant
• Subject with contraindication(s) to or inability to undergo a PET/MR or PET/CT
• Known allergy to 18F-Fluciclovine or any of its excipients

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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