Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT05554302
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-Fluciclovine — DRUG
    Patients 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.

Study Details

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.

Key Dates

Start date
Jan 10, 2023
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PET/CT, MRI
    All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure.

Primary Outcome Measure

Change in conformality index of tumor target volume delineation [ Time Frame: 3 weeks, 6 and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health South FloridaMiamiFlorida33176
Rupesh Kotecha, MD
[email protected]
786-527-7642
Rupesh Kotecha, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Miami Cancer Institute at Baptist Health South Florida· Miami, FL

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