Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age ≥18 years
Performance status, Eastern Cooperative Oncology Group 0-2
Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
Plan for SSRS per the treating team
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
Design model
Single group
Treatments tested in this trial
18F fluciclovine
DrugPatients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PET/CT, MRIOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in sensitivity for PET/CT
Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.
Time frame
through study completion, an average of 1 year2
Change in sensitivity for MRI
To calculate the sensitivity of pre-treatment contrast-enhanced MRI.
Time frame
through study completion, an average of 1 year3
Change in the standardized uptake value (SUV) parameters
To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Compare change of SUV metrics of 18F-fluciclovine PET
To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake
Time frame
baseline2
Compare change of SUV metrics of contrast-enhanced MRI
To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baptist Health South Florida
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov