[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-her2-expression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-her2-expression":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":5},"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":18,"type":19},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.",[23,24],"Breast Cancer","Breast Cancer, HER2-Expression","RECRUITING","2025-04-27",{"date":28,"type":29},"2025-04-30","ACTUAL",{"date":31,"type":29},"2025-04-09",{"date":33,"type":19},"2027-12",{"name":35,"class":36},"The Affiliated Hospital of Qingdao University","OTHER",""]