Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
Radiographic diagnosis of brain metastasis
Patient planned for surgical intervention for at least 1 metastasis
Disqualifiers
Prior anaphylactic reaction to 18F-Fluciclovine
Evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
Trial design
Treatments tested in this trial
- 18F-Fluciclovine
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Baptist Health South Florida
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov