Recruiting
Phase 3

18F-FLUC-CEST

Sponsor:

University of Wisconsin, Madison

Code:

NCT06159335

Conditions

Brain Metastasis

Radiation Therapy

Immunotherapy, Active

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

F-Fluciclovine radiotracer

Study Details

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

Study ID

NCT06159335

Start date

Jan 10, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PET-MRI

Participants will undergo F-Fluciclovine PET radiotracer and MRI

Interventions

F-Fluciclovine radiotracer

Participants will receive PET radiotracer and MRI

Primary outcome measure

  • Amino acid uptake into tumor tissue [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349radstudy@uwhealth.org

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-22.