18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)

Trial ID: NCT06048094

Interventional - Phase 1 - Recruiting

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.

Conditions

• Brain Metastases
• Brain Metastases, Adult
• Brain Cancer

Interventions

• 18F fluciclovine

Eligibility

Inclusion criteria

• 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
• Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET

Exclusion criteria

• 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)
• Pregnant or positive serum pregnancy test within 14 days of registration
• Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
• Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\*
• A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.

Sponsor

Baptist Health South Florida, Blue Earth Diagnostics

Source: ClinicalTrials.gov

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