[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647452":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[68Ga]Ga-FFD PET Imaging","EXPERIMENTAL","Participants will receive a single intravenous administration of \\[68Ga\\]Ga-FFD followed by serial whole-body PET\u002FCT imaging. Healthy volunteers will undergo imaging for biodistribution and radiation dosimetry evaluation, while patients with malignant solid tumors will additionally undergo standard-of-care \\^18F-FDG PET\u002FCT imaging for assessment of diagnostic performance.",[13],"Drug: [68Ga]Ga-FFD",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[68Ga]Ga-FFD","For Cancer patients, \\[68Ga\\]Ga-FFD is a gallium-68-labeled PET radiotracer administered as a single intravenous injection at approximately 185 MBq (5 mCi ±10%) for molecular imaging. Whole-body PET\u002FCT imaging will be performed at approximately 0.5 and 2 hours after administration to evaluate tracer biodistribution, radiation dosimetry, safety, and diagnostic performance.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xiaoli Lan","CONTACT","0086-027-83692633","lxl730724@hotmail.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Union Hospital, Huazhong University of Science and Technology","Wuhan","Hubei","China","CN",{"type":35,"coordinates":36},"Point",[37,38],114.26667,30.58333,{"lat":38,"lon":37},[41,42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":20,"role":24,"phone":20,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100647452","early-phase-1-clinical-evaluation-of-68gaga-ffd-pet-imaging-in-healthy-volunteers-and-patients-with-solid-tumors-100647452",false,"NCT07708103","Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors","A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors","Inclusion Criteria:\n\n* Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.\n* Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.\n* ECOG performance status of 0-1 for patients.\n* Clinical indication for \\^18F-FDG PET\u002FCT imaging (patient cohort only).\n* Adequate organ function.\n* Willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.\n* Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.\n* Active uncontrolled infection requiring systemic treatment.\n* Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.\n* Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).\n* Inability to undergo PET\u002FCT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.",true,"ALL","18 Years",{"count":56,"type":57},12,"ESTIMATED","INTERVENTIONAL",[60],"EARLY_PHASE1","This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \\[68Ga\\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \\[68Ga\\]Ga-FFD PET imaging in addition to standard-of-care \\^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.",[63],"Solid Tumor Malignancies",[65,66,67,68],"pet","Solid Tumor","Biodistribution","Diagnostic Imaging","NOT_YET_RECRUITING","2026-07-12",{"date":72,"type":73},"2026-07-16","ACTUAL",{"date":75,"type":57},"2026-07-30",{"date":77,"type":57},"2027-07-30",{"name":5,"class":6},1]