18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of cancer with radiographic finding of brain metastasis
Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
Planned treatment with SRS as per the treating physician team
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Disqualifiers
Prior anaphylactic reaction to 18F-fluciclovine
Radiographic evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Inability to undergo 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
DrugParticipants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection 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
46 Participants
are divided into 1 treatment groupGroup A: 18F-Fluciclovine PET ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Standardized Uptake Value (SUV)-peak
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time frame
8 weeks2
Change in SUVmean
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time frame
8 weeks3
Change in SUVmax
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time frame
8 weeksSecondary outcomes
1
Tumor Control
Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame
12 monthsSponsors and contacts
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Baptist Health South Florida
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov