[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622617":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Recipients with Malignant solid tumors",null,"Participants:\n\nPatients (≥18 years) with highly suspected or pathologically confirmed malignant tumors, or patients with suspected recurrence of malignant tumors after treatment\n\nInterventions:\n\n68Ga-B6FA-01 PET\u002FCT scan prior to therapy.\n\nObjectives:\n\n* Evaluate the diagnostic efficacy of 68Ga-B6FA-01 PET in malignant solid tumors.\n* Evaluate the safety and tolerability, biological distribution, radiation dose, and pharmacokinetic characteristics of 68Ga-B6FA-01 in cancer patients.\n* Evaluate the relationship between quantitative parameters of PET imaging and pathological indicators Design: Single-arm observational study; PET parameters (SUVmax, tumor-to-background ratio, et al) will be correlated with clinical outcomes.",[13],"Diagnostic Test: PET\u002FCT Imaging with αvβ6\u002FFAP-targeted tracer",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","PET\u002FCT Imaging with αvβ6\u002FFAP-targeted tracer","Intravenous administration of αvβ6\u002FFAP-targeted tracer (111\\~185 MBq), followed by whole-body PET\u002FCT scan 30\\~60 minutes post-injection.",[9],[21],{"name":22,"affiliation":5,"role":23},"Yong He, MD, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+86-27-67812698","heyong@whu.edu.cn",[30],{"facility":31,"status":10,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071","China","CN",{"type":38,"coordinates":39},"Point",[40,41],114.26667,30.58333,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":10,"email":47},"Yaqun Jiang, MD, PhD","+86 27 67812698","zn004239@whu.edu.cn",{"type":23,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Yong He","Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University","100622617","evaluation-of-the-diagnostic-efficacy-of-a-v6fap-targeting-heterodimeric-probe-in-patients-with-malignant-solid-tumors-100622617",false,"NCT07385950","Evaluation of the Diagnostic Efficacy of a αvβ6\u002FFAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors","Evaluation of Diagnostic Efficacy of a αvβ6\u002FFAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors: An Open-Label, Single-Arm, Single-Center Study","Inclusion Criteria:\n\n1. Voluntarily provide written informed consent.\n2. Age ≥ 18 years.\n3. Newly diagnosed with a clinically\u002Fradiologically suspected or pathologically confirmed malignant solid tumor, or with suspected recurrence after prior treatment.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n5. Life expectancy \\> 6 months.\n6. Participants of childbearing potential and their partners must agree to use highly effective contraception for 6 months following the last dose of the investigational agent.\n\nExclusion Criteria:\n\n1. Prior radioisotope therapy within an interval less than 10 times the physical half-life of the respective radionuclide before study administration.\n2. Concurrent participation in any other interventional clinical trial.\n3. Known allergy or hypersensitivity to the investigational agent or any of its excipients.\n4. Inability to lie still for the duration of the PET scan or any condition contraindicating PET imaging.\n5. Pregnancy or lactation.\n6. Any other condition that, in the investigator's judgment, would compromise participant safety or study integrity.","ALL","18 Years","90 Years",{"count":62,"type":63},100,"ESTIMATED","OBSERVATIONAL","Malignant tumors pose a grave threat to human health and impose a substantial burden on society. Molecular imaging, which enables non-invasive, in vivo visualization of biological processes at the molecular level, is crucial for early diagnosis and treatment monitoring, thereby improving clinical management. Currently, molecular probes targeting fibroblast activation protein (FAP) and integrin αvβ6, such as ⁶⁸Ga-labeled FAPI and ⁶⁸Ga-Trivehexin, have shown promise in oncologic PET imaging, yet each has limitations.\n\nFAP is predominantly overexpressed in cancer-associated fibroblasts within the tumor stroma, with minimal expression in normal tissues. However, radiotracers like ⁶⁸Ga-FAPI often exhibit physiological uptake in normal organs (e.g., salivary glands, pancreas, uterus), leading to elevated background signals and potentially reduced diagnostic contrast. Conversely, integrin αvβ6 is primarily expressed on tumor cell surfaces and is upregulated in many malignancies. Nonetheless, probes like ⁶⁸Ga-Trivehexin suffer from high renal retention with slow clearance and notable physiological gastrointestinal uptake, resulting in suboptimal target-to-background ratios and compromised image quality.\n\nGiven the complementary expression profiles of FAP (stroma) and integrin αvβ6 (tumor cells), we hypothesize that a bispecific molecular probe capable of simultaneously engaging both targets could achieve superior tumor targeting through a synergistic \"dual-lock\" mechanism. This prospective exploratory clinical trial aims to evaluate the diagnostic efficacy and safety of a novel bispecific probe, named ⁶⁸Ga-B6FA-01, in patients with malignant solid tumors. The ultimate goal is to develop a superior imaging strategy for early and precise tumor diagnosis, treatment response assessment, and personalized therapeutic decision-making.",[67,68,69],"PET \u002F CT","Solid Tumors","Adult",[71,72,73,74],"integrin αVβ6","FAP","PET imaging","Diagnostic efficacy","NOT_YET_RECRUITING","2026-01-26",{"date":78,"type":79},"2026-02-04","ACTUAL",{"date":81,"type":63},"2026-01-15",{"date":83,"type":63},"2028-12-31",{"name":5,"class":6},1]