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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Baptist Health South Florida · Participants: 46 · Started: Apr 11, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06048094

Locations in the U.S.

FloridaMiami Cancer Institute, Miami

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.