18F-FLUC PET/MR in Patients With Brain Mets
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
F-Fluciclovine radiotracer
RadiationParticipants will receive PET radiotracer and MRI
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PET-MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amino acid uptake into tumor tissue
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
Time frame
3 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov