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

• Status: Recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baptist Health South Florida
• Collaborator: Blue Earth Diagnostics

Criteria

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.