Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2024-01-10
2026-06-30
Brief Summary
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Participants will undergo a single PET/MRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.
Detailed Description
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This study aims to evaluate imaging methods known as PET and MRI to improve detection of cancerous tissue better than the types of imaging that are currently available.
These methods are conducted on the same machine as conventional MRI that uses a powerful magnet, radio waves, and a computer to create detailed images. Both the PET and MRI methods look at the number of proteins a tumor has. The more proteins, the more likely there is tumor relative to normal brain tissue.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET-MRI
Participants will undergo F-Fluciclovine PET radiotracer and MRI
F-Fluciclovine radiotracer
Participants will receive PET radiotracer and MRI
Interventions
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F-Fluciclovine radiotracer
Participants will receive PET radiotracer and MRI
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Michael Veronesi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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NCI-2024-06018
Identifier Type: REGISTRY
Identifier Source: secondary_id
Protocol Version 4/16/2025
Identifier Type: OTHER
Identifier Source: secondary_id
A539300
Identifier Type: OTHER
Identifier Source: secondary_id
UW23061
Identifier Type: OTHER
Identifier Source: secondary_id
2023-1082
Identifier Type: -
Identifier Source: org_study_id