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NCT06048094PHASE1Recruiting

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

Baptist Health South Florida

Start Date

4/11/2024

Completion Date

5/1/2033

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

18F fluciclovine

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Conditions

Brain MetastasesBrain Metastases, AdultBrain Cancer

Locations

Miami Cancer Institute

Miami, Florida 33176

United States