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Life sciences · Observational Study
ClinicalTrials.gov · September 17, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06916637). This is a study registration, not published results. Lead sponsor: The Affiliated Hospital of Qingdao University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Breast Cancer, Breast Cancer, HER2-Expression. Interventions: RADIATION: 18F-HER2 Affibody PET scan. Primary outcome measures: SUV , 2 years. Brief summary: 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.