[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551043":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":23,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Each patient must undergo dynamic PET\u002FCT imaging with [68Ga]B7H3 Affibody-BCH.","EXPERIMENTAL",null,[13],"Drug: [68Ga] B7H3 Affibody-BCH",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","[68Ga] B7H3 Affibody-BCH","An affibody structure specifically targeting B7H3 was developed based on the B7H3 binding domain, and it was structurally optimized to yield a small molecular agent, B7H3 Affibody-BCH, suitable for nuclear medical diagnostic and therapeutic uses targeting B7H3. By labeling with the radioactive isotope \\^68Ga, this agent can be used for PET\u002FCT diagnosis of solid tumors.",[9],[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Xiangxi Meng","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Xiangxi Meng, PhD","CONTACT","01088197852","mengxiangxi@pku.edu.cn",{"name":42,"role":38,"phone":43,"phoneExt":11,"email":44},"Lei Xia, PhD","01088197853","xialei9012288@126.com",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100551043","early-phase-1-study-on-b7-h3-targeted-affibody-radioligand-probes-for-pet-imaging-of-solid-tumors-100551043",false,"NCT06454955","Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors","Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET","Inclusion Criteria:\n\n1. Age range 18-75 years, open to both male and female participants;\n2. Participants must meet the following hematologic and hepatic\u002Frenal function criteria: Hematology: WBC ≥ 4.0 × 10\\^9\u002FL or neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL; Prothrombin time (PT) or Activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT\u002FAST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;\n3. Normal cardiac function;\n4. Expected survival of at least 12 weeks;\n5. Good adherence to follow-up;\n6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;\n7. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;\n8. Patients for whom a clinical physician recommends PET\u002FCT scans for the diagnosis and staging of tumors;\n9. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Severe abnormalities in liver and renal function and blood counts;\n2. Patients planning to conceive;\n3. Pregnant or lactating women;\n4. Individuals unable to lie flat for thirty minutes;\n5. Individuals who refuse to participate in this clinical study;\n6. Individuals suffering from claustrophobia or other psychiatric disorders;\n7. Other situations deemed unsuitable for trial participation by the researchers.",true,"ALL","18 Years","75 Years",{"count":59,"type":60},50,"ESTIMATED","INTERVENTIONAL",[63],"EARLY_PHASE1","Based on \\[68Ga\\]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of \\[68Ga\\]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.",[66,67,68],"B7H3","CD276 Affibody","PET\u002FCT Imaing","2024-08-21",{"date":71,"type":72},"2024-08-23","ACTUAL",{"date":74,"type":72},"2024-01-01",{"date":76,"type":60},"2026-11-30",{"name":5,"class":6},1]