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

NCT06159335 | Recruiting Phase 3 DMC FDA Device

• 5 other identifiers: 2023-1082NCI-2024-06018Protocol Version 11/20/2025A539300UW23061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Metastasis; Radiation Therapy; Immunotherapy, Active

Outcome Measures

Primary Outcomes (1)

• Amino acid uptake into tumor tissue

  Using 18F-Fluciclovine PET, compare amino acid uptake into brain tumor tissue with uptake in normal brain tissue. Higher uptake is hypothesized to indicate malignancy

  3 hours

Study Arms (1)

PET-MRI

EXPERIMENTAL

Participants will undergo F-Fluciclovine PET radiotracer and MRI

Radiation: F-Fluciclovine radiotracer

Interventions

F-Fluciclovine radiotracer RADIATION

Participants will receive PET radiotracer and MRI

PET-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Michael Veronesi, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; radstudy@uwhealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)