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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
18F-Fluciclovine
DrugPatients will receive 5-mCi dose (+/- 20%) 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, MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in conformality index of tumor target volume delineation
The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.
Time frame
3 weeks, 6 and 12 months2
Change in PET scan standardized uptake value (SUV) parameters
The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.
Time frame
3 weeks, 6 and 12 monthsSecondary outcomes
1
Time to local failure
Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event.
Time frame
1 yearSponsors and contacts
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Baptist Health South Florida
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov