[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539059":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":118,"collaborators":24,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":24,"enrollmentInfo":130,"targetDuration":24,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":145,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Lantheus Medical Imaging","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Part 1","EXPERIMENTAL","6 patients will receive 8 ± 1 mCi (\\~90 μg mass dose) of the 64Cu-LNTH-1363S on Day 1 in the Intervention Period (raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with 6 mCi and 4 mCi 64Cu injected activities).",[13],"Combination Product: 64Cu-LNTH-1363S",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental Part 2","First 6 evaluable patients will receive the optimal radioactivity determined in Part 1. The remaining 14 evaluable patients will receive either the optimal radioactivity determined in Part 1 (if the sum of the average image quality scores of the first 6 patients is higher or equal to 10.5), or 8 ± 1 mCi (if the sum of the average image quality scores of the first 6 patients is less than 10.5).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","64Cu-LNTH-1363S","64Cu-LNTH-1363S, is a highly selective, high affinity FAP inhibitor (FAPi) that is radiolabeled with Copper-64 (64Cu) for PET\u002FCT Imaging,",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Eryn Bagley","CONTACT","978-671-8886","clinicaltrials@lantheus.com",[32,54,69,85,102],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.97729,34.13945,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Jessica Liu, Clinical Research Nurse","(626)218-0473","Jesliu@coh.org",{"name":52,"role":53,"phone":24,"phoneExt":24,"email":24},"Yufei Liu, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":34,"city":56,"state":36,"zip":57,"country":38,"countryCode":39,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"UC Irvine Health - Chao Family Comprehensive Cancer Center","Orange","92868",{"type":41,"coordinates":59},[60,61],-117.85311,33.78779,{"lat":61,"lon":60},[64,68],{"name":65,"role":28,"phone":66,"phoneExt":24,"email":67},"Shyam Srinivas, MD, PhD","877-827-8839","ucstudy@uci.edu",{"name":65,"role":53,"phone":24,"phoneExt":24,"email":24},{"facility":70,"status":34,"city":71,"state":36,"zip":72,"country":38,"countryCode":39,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Stanford Hospital & Clinics","Stanford","94305",{"type":41,"coordinates":74},[75,76],-122.16608,37.42411,{"lat":76,"lon":75},[79,83],{"name":80,"role":28,"phone":81,"phoneExt":24,"email":82},"Mikayla Easterling","650-724-3698","maeast@stanford.edu",{"name":84,"role":53,"phone":24,"phoneExt":24,"email":24},"Farshad Moradi, MD",{"facility":86,"status":34,"city":87,"state":88,"zip":89,"country":38,"countryCode":39,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"BAMF Health, Inc.","Grand Rapids","Michigan","49503",{"type":41,"coordinates":91},[92,93],-85.66809,42.96336,{"lat":93,"lon":92},[96,100],{"name":97,"role":28,"phone":98,"phoneExt":24,"email":99},"Kevin Quinn","616-330-2735","researchclinicalteam@bamfhealth.com",{"name":101,"role":53,"phone":24,"phoneExt":24,"email":24},"Harshad Kulkarni, MD",{"facility":103,"status":34,"city":104,"state":105,"zip":106,"country":38,"countryCode":39,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229-3039",{"type":41,"coordinates":108},[109,110],-84.51439,39.12711,{"lat":110,"lon":109},[113,117],{"name":114,"role":28,"phone":115,"phoneExt":24,"email":116},"Brian Turpin, MD","1-513-636-2799","cancer@cchmc.org",{"name":114,"role":53,"phone":24,"phoneExt":24,"email":24},{"type":119,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100539059","phase-1-64cu-lnth-1363s-in-patients-with-sarcoma-or-gastrointestinal-tract-cancer-100539059",false,"NCT06298916","64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer","A Phase 1\u002F2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET\u002FCT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)","PHANTOM","Inclusion Criteria: Part 1\n\nPatients are eligible to be included in the study only if all of the following criteria apply:\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients with suspected FAP-expressing metastatic sarcoma.\n3. Patients must have histological, pathological, and\u002For cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).\n4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nInclusion Criteria: Part 2\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients must have histological, pathological, and\u002For cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.\n3. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).\n4. Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nExclusion Criteria: Part 1\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.\n2. Known pregnancy or breastfeeding.\n3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n4. Patients participating in another clinical trial at the time of screening for this study.\n5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.\n6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n7. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking medication known to cause QT\u002FQTc prolongation.\n8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n\nExclusion Criteria: Part 2\n\n1. Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.\n2. Evidence of metastatic or advanced, inoperable disease.\n3. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.\n4. Known pregnancy or breastfeeding.\n5. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n6. Patients participating in another clinical trial at the time of screening for this study.\n7. Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n8. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking drugs known to cause QT\u002FQTc prolongation.\n9. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome","ALL","15 Years",{"count":131,"type":132},26,"ESTIMATED","INTERVENTIONAL",[135,136],"PHASE1","PHASE2","This is a multicenter, open-label, prospective Phase 1\u002F2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).",[139,140,141,142,143,144],"Metastatic Sarcoma","Esophageal Cancer","Gastric Cancer","Pancreatic Cancer","Colorectal Cancer","Sarcoma",[146,147,21],"FAPi","Imaging","2025-08-06",{"date":150,"type":151},"2025-08-12","ACTUAL",{"date":153,"type":132},"2025-08",{"date":155,"type":132},"2026-04",{"name":5,"class":6},5]