[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519787":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":33,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":41,"whyStopped":33,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Baptist Health South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-Fluciclovine PET Imaging","EXPERIMENTAL","Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.",[13],"Drug: 18F fluciclovine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F fluciclovine","Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection 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.",[9],[21,22,23],"Axumin","18F-FACBC","(1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid",[25],{"name":26,"affiliation":27,"role":28},"Rupesh Kotecha, M.D.","Miami Cancer Institute at Baptist Health, Inc.","PRINCIPAL_INVESTIGATOR",[30,35],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","(786) 596-2000",null,"RupeshK@baptisthealth.net",{"name":36,"role":31,"phone":32,"phoneExt":33,"email":37},"Kristy Reyes","Kristina.Reyes@baptisthealth.net",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Miami Cancer Institute","RECRUITING","Miami","Florida","33176","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-80.19366,25.77427,{"lat":51,"lon":50},[54,56],{"name":26,"role":31,"phone":55,"phoneExt":33,"email":34},"786-596-2000",{"name":36,"role":31,"phone":32,"phoneExt":33,"email":37},{"type":58,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[60],{"name":61,"class":62},"Blue Earth Diagnostics","INDUSTRY","100519787","phase-1-18f-fluciclovine-pet-amino-acid-evaluation-of-brain-metastasis-treated-with-stereotactic-radiosurgery-100519787",false,"NCT06048094","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)","FACILITATE","Inclusion Criteria:\n\n* Diagnosis of cancer with radiographic finding of brain metastasis\n* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension\n* Planned treatment with SRS as per the treating physician team\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* 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\n\nExclusion Criteria:\n\n* Prior anaphylactic reaction to 18F-fluciclovine\n* Radiographic evidence of leptomeningeal disease\n* Prior whole-brain radiation therapy\n* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n* Pregnant or positive serum pregnancy test within 14 days of registration\n* 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.\n* Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For preclude informed consent\\*\n\n  * 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.","ALL","18 Years",{"count":74,"type":75},46,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","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.",[81,82,83],"Brain Metastases","Brain Metastases, Adult","Brain Cancer",[85,86,87],"stereotactic radiosurgery","18F-flucicloivine","PET imaging","2026-05-18",{"date":90,"type":91},"2026-05-20","ACTUAL",{"date":93,"type":91},"2024-04-11",{"date":95,"type":75},"2033-05",{"name":5,"class":6},1]