Status:
RECRUITING
18F-FLUC PET/MR in Patients With Brain Mets
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Brain Metastasis
Radiation Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ans...
Detailed Description
The purpose of this research is to utilize new imaging methods to aid in assessing whether imaging shows presence of tumor. Developing imaging technologies is critical for more accurately identifying ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06159335
Start Date
January 10 2024
End Date
June 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705