Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-75 years, ECOG score 0 or 1.
Clinically or pathologically confirmed diagnosis of patients with HER2 expression breast cancer or suspected expression breast cancer.
Life expectancy ≥ 12 weeks.
At least one measurable target lesion according to RECIST 1.1 criteria.
Disqualifiers
Severe hepatic or renal dysfunction.
Pregnant or lactating women, or women planning to become pregnant.
Inability to lie supine for half an hour.
Refusal to participate in this clinical study.
Trial design
Treatments tested in this trial
- 18F-HER2 Affibody PET scan
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov