Clinical trial · Interventional
18F-FLUC PET/MR in Patients With Brain Mets
Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | — | UNRESOLVED | — |
| Immunotherapy, Active | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F-Fluciclovine radiotracer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET-MRI
- description
- Participants will undergo F-Fluciclovine PET radiotracer and MRI
- interventionNames
- Radiation: F-Fluciclovine radiotracer
Primary outcomes (1)
- measure
- Amino acid uptake into tumor tissue
- timeFrame
- 3 hours
- description
- Using 18F-Fluciclovine PET, compare amino acid uptake into brain tumor tissue with uptake in normal brain tissue. Higher uptake is hypothesized to indicate malignancy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available