[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06048094":3,"trial-entities:NCT06048094":130,"trial-summary:NCT06048094":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":55,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":80,"locations":83,"central_contacts":103,"overall_officials":106,"references":110,"see_also_links":127},"NCT06048094","2022-KOT-003","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)","RECRUITING","2033-05","2026-05","2026-05-20","2024-04-11","Baptist Health South Florida","OTHER",true,"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.",null,[19,20,21],"Brain Metastases","Brain Metastases, Adult","Brain Cancer",[23,24,25],"stereotactic radiosurgery","18F-flucicloivine","PET imaging","INTERVENTIONAL","DIAGNOSTIC",[29],"PHASE1",{"count":31,"type":32},46,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"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.",[39],"18F-Fluciclovine PET Imaging",[41,42,43],"Axumin","18F-FACBC","(1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid",[45,49,52],{"measure":46,"description":47,"timeFrame":48},"Change in Standardized Uptake Value (SUV)-peak","Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.","8 weeks",{"measure":50,"description":51,"timeFrame":48},"Change in SUVmean","Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.",{"measure":53,"description":54,"timeFrame":48},"Change in SUVmax","Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.",[56],{"measure":57,"description":58,"timeFrame":59},"Tumor Control","Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.","12 months","ALL","18 Years",false,{"inclusion":64,"exclusion":70,"raw_text":79},[65,66,67,68,69],"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",[71,72,73,74,75,76,77,78],"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\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For 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.","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.",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":100},"Miami Cancer Institute","Miami","Florida","33176","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Rupesh Kotecha, M.D.","CONTACT","786-596-2000","RupeshK@baptisthealth.net",{"name":97,"role":93,"phone":98,"email":99},"Kristy Reyes","(786) 596-2000","Kristina.Reyes@baptisthealth.net",{"lat":101,"lon":102},25.77427,-80.19366,[104,105],{"name":92,"role":93,"phone":98,"email":95},{"name":97,"role":93,"phone":98,"email":99},[107],{"name":92,"affiliation":108,"role":109},"Miami Cancer Institute at Baptist Health, Inc.","PRINCIPAL_INVESTIGATOR",[111,115,118,121,124],{"pmid":112,"type":113,"citation":114},"28277832","BACKGROUND","Galldiks N, Langen KJ. Amino acid PET in neuro-oncology: applications in the clinic. Expert Rev Anticancer Ther. 2017 May;17(5):395-397. doi: 10.1080\u002F14737140.2017.1302799. Epub 2017 Mar 11. No abstract available.",{"pmid":116,"type":113,"citation":117},"26022202","Doi Y, Kanagawa M, Maya Y, Tanaka A, Oka S, Nakata N, Toyama M, Matsumoto H, Shirakami Y. Evaluation of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid accumulation in low-grade glioma in chemically induced rat models: PET and autoradiography compared with morphological images and histopathological findings. Nucl Med Biol. 2015 Aug;42(8):664-72. doi: 10.1016\u002Fj.nucmedbio.2015.04.008. Epub 2015 May 7.",{"pmid":119,"type":113,"citation":120},"33284388","Parent EE, Patel D, Nye JA, Li Z, Olson JJ, Schuster DM, Goodman MM. [18F]-Fluciclovine PET discrimination of recurrent intracranial metastatic disease from radiation necrosis. EJNMMI Res. 2020 Dec 7;10(1):148. doi: 10.1186\u002Fs13550-020-00739-6.",{"pmid":122,"type":113,"citation":123},"34406623","Wakabayashi T, Hirose Y, Miyake K, Arakawa Y, Kagawa N, Nariai T, Narita Y, Nishikawa R, Tsuyuguchi N, Fukami T, Sasaki H, Sasayama T, Kondo A, Iuchi T, Matsuda H, Kubota K, Minamimoto R, Terauchi T, Nakazato Y, Kubomura K, Wada M. Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET\u002FCT in patients with suspected glioma: multicenter phase III trials. Ann Nucl Med. 2021 Dec;35(12):1279-1292. doi: 10.1007\u002Fs12149-021-01670-z. Epub 2021 Aug 18.",{"pmid":125,"type":113,"citation":126},"17189070","Gondi V, Bradley K, Mehta M, Howard A, Khuntia D, Ritter M, Tome W. Impact of hybrid fluorodeoxyglucose positron-emission tomography\u002Fcomputed tomography on radiotherapy planning in esophageal and non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):187-95. doi: 10.1016\u002Fj.ijrobp.2006.09.033.",[128],{"label":85,"url":129},"http:\u002F\u002Fcancer.baptisthealth.net\u002F",{"nct_id":4,"conditions":131,"biomarkers":134},[132,133],"Malignant Brain Neoplasm","Metastatic Malignant Neoplasm in the Brain",[],{"nct_id":4,"found":15,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is a pilot imaging study involving 46 participants. It is designed to see if 18F-Fluciclovine PET can be used as a biomarker.","completed","18F-Fluciclovine PET Evaluation for Brain Metastasis After Stereotactic Radiosurgery","This study is testing if a special type of imaging, called 18F-Fluciclovine PET (positron emission tomography), can help doctors see how brain metastases (cancers that have spread to the brain) respond to treatment with stereotactic radiosurgery (SRS). You might be able to join if you are an adult with brain metastases that are 2 cm or smaller, and you are planning to have SRS. The study will look at changes in how much of the 18F-Fluciclovine is absorbed by the brain metastases after 8 weeks to see if this imaging can be a good way to measure treatment success or if the cancer is growing. The current recruitment status is unclear, and the study plans to enroll 46 participants.","The primary endpoints are measured at 8 weeks after the intervention.",119,"Participants will receive an intravenous injection of 18F-Fluciclovine immediately before PET data collection, which will last up to 25 minutes. This will happen at least once, with measurements taken at 8 weeks.","Not stated in the trial record.",[],"v2"]