NCT06159335 18F-FLUC PET/MR in Patients With Brain Mets
| NCT ID | NCT06159335 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Brain Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2024-01-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Michael Veronesi, MD, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06159335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06159335 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT06159335 currently recruiting?
Yes, NCT06159335 is actively recruiting participants. Contact the research team at radstudy@uwhealth.org for enrollment information.
Where is the NCT06159335 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06159335 clinical trial?
NCT06159335 is sponsored by University of Wisconsin, Madison. The principal investigator is Michael Veronesi, MD, PhD at University of Wisconsin, Madison. The trial plans to enroll 30 participants.