Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

New imaging methods for detecting brain tumors in patients with metastasis

Official title: Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy

Run by University of Wisconsin, Madison · NCT06159335 · Data updated 2026-11-12

This study is testing new imaging techniques to see if they can better detect brain tumors in patients who have cancer that has spread to the brain.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedJanuary 10, 2024
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedJune 22, 2026
Trial IDNCT06159335 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 years or older with a diagnosed brain metastasis and at least one visible contrast-enhancing lesion on MRI.

Probably not a fit

Patients without a diagnosis of brain metastasis or those who have not received radiation therapy in the last two years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of advanced imaging techniques, specifically positron emission tomography (PET) and magnetic resonance imaging (MRI), in detecting cancerous tissue in patients with brain metastasis. Participants will undergo a PET/MRI scan followed by a separate MRI scan with a tracer, with the entire process lasting about three hours. The study seeks to determine if these new imaging methods can identify tumors more accurately than existing imaging technologies, potentially leading to better cancer treatment outcomes.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of tumor detection in patients with brain metastasis, leading to more effective treatment strategies.

How similar studies have gone: Other studies have shown promise in using advanced imaging techniques for tumor detection, suggesting that this approach may yield beneficial results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Michael Veronesi, MD, PhD — University of Wisconsin, Madison
  • Study coordinator: Radiology Studies
  • Email: radstudy@uwhealth.org
  • Phone: 608-282-8349

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.