[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575249":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":33,"responsibleParty":50,"collaborators":21,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":17,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Koo Foundation Sun Yat-Sen Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ga-68-FAPI-46 PET scan in colorectal cancer","EXPERIMENTAL","Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET.",[13],"Drug: Ga-68-FAPI-46",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":19},"DRUG","Ga-68-FAPI-46",[9],[20],"PET\u002FCT",null,[23,29],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Yu Yi Huang, MD","CONTACT","+886 28970011","1121","yuyi@kfsyscc.org",{"name":30,"role":25,"phone":26,"phoneExt":31,"email":32},"Cheng Ling Yang, B.Rad.","1167","androgyny@kfsyscc.org",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Taipei","Beitou","1125019","Taiwan","TW",{"type":42,"coordinates":43},"Point",[44,45],121.52639,25.05306,{"lat":45,"lon":44},[48,49],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},{"name":30,"role":25,"phone":26,"phoneExt":31,"email":32},{"type":51,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100575249","ga-68-fapi-46-pet-for-crc-recurrence-detection-in-elevated-cea-100575249",false,"NCT06769828","Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA","Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance","Inclusion Criteria:\n\n* Age ≥ 20 years old\n* The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.\n* Elevated serum CEA levels:\n\nExceeding the laboratory's normal range (5 ng\u002Fml) or, but not surpassing 13 ng\u002Fml; using the individual's post-surgery +\u002F- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.\n\n* Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.\n* Signing the subject consent form.\n* ECOG grade 0-2.\n* The timing of F-18-FDG usage in this trial follows the \" 2023 - Colorectal Cancer Treatment Principles\" of our institution.\n\nExclusion Criteria:\n\n* pregnant woman and breastfeeding women\n* severe renal impairment (eGRF\\\u003C 30ml\u002Fmin)\n* Known or suspected allergy to radiopharmaceuticals\n* Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.\n* Inability to undergo the necessary PET scan procedure\n* Refusal or unwillingness to sign the informed consent form\n* Severe medical conditions (severe disabilities, mental disorders)","ALL","20 Years","100 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.",[70],"Colorectal Cancer Recurrent",[72,73],"Ga-68-FAPI-46 PET\u002FCT","Colorectal cancer (CRC)","2025-01-19",{"date":76,"type":77},"2025-01-22","ACTUAL",{"date":79,"type":64},"2025-02-01",{"date":81,"type":64},"2026-04-14",{"name":5,"class":6},1]