[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586535":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":39,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"18F-HER2 Affibody PET scan",null,[12],"Radiation: 18F-HER2 Affibody PET scan",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"RADIATION","HER2 Affibody, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-HER2 Affibody PET scan.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Zhenguang Wang, Doctoral Degree","CONTACT","+86-0532-82913318","wangzhenguang@qdu.edu.cn",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"Affiliated Hospital of Qingdao University","RECRUITING","Qingdao","Shandong","266000","China","CN",{"type":34,"coordinates":35},"Point",[36,37],120.38042,36.06488,{"lat":37,"lon":36},{"type":40,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100586535","clinical-study-on-the-application-of-18f-her2-affibody-pet-imaging-in-her2-expressing-breast-cancer-100586535",false,"NCT06916637","Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer","Inclusion Criteria:\n\n* Age 18-75 years, ECOG score 0 or 1.\n* Clinically or pathologically confirmed diagnosis of patients with HER2 expression breast cancer or suspected expression breast cancer.\n* Life expectancy ≥ 12 weeks.\n* At least one measurable target lesion according to RECIST 1.1 criteria.\n* All participants of reproductive potential (regardless of gender) must commit to using effective contraceptive methods throughout the trial participation and for 6 months after the last PET scan.\n* Ability to understand and voluntarily sign the informed consent form, with good compliance.\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction.\n* Pregnant or lactating women, or women planning to become pregnant.\n* Inability to lie supine for half an hour.\n* Refusal to participate in this clinical study.\n* Suffering from claustrophobia or other mental illnesses.\n* Other conditions that the investigator deems unsuitable for participation in the trial.","ALL","18 Years","75 Years",{"count":51,"type":52},40,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the clinical utility of 18F-labeled HER2 Affibody PET for diagnosing and monitoring HER2-expressing breast cancer. HER2, a protein overexpressed in certain malignancies including breast cancer, serves as a critical biomarker for targeted therapies.The HER2 Affibody-an engineered 7 kDa protein with nanomolar affinity for HER2-leverages its rapid tumor penetration and clearance kinetics to achieve high-contrast PET imaging. This study aims to evaluate the diagnostic efficacy of 18F-HER2 Affibody PET in early detection, clinical staging, and treatment response monitoring, thereby providing novel imaging evidence to guide personalized therapeutic strategies for patients with HER2-expressing breast cancer.",[56,57],"Breast Cancer","Breast Cancer, HER2-Expression","2025-04-27",{"date":60,"type":61},"2025-04-30","ACTUAL",{"date":63,"type":61},"2025-04-09",{"date":65,"type":52},"2027-12",{"name":5,"class":6},1]