Actively Recruiting
Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Led by The Affiliated Hospital of Qingdao University · Updated on 2025-04-30
40
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years with ECOG score 0 or 1
- Clinically or pathologically confirmed or suspected HER2-expressing breast cancer
- Life expectancy of at least 12 weeks
- At least one measurable target lesion according to RECIST 1.1 criteria
- Commitment to use effective contraception during the study and for 6 months after the last PET scan if of reproductive potential
- Ability to understand and voluntarily sign informed consent with good compliance
You will not qualify if you...
- Severe liver or kidney dysfunction
- Pregnant or lactating women, or planning pregnancy
- Unable to lie flat on back for 30 minutes
- Refusal to participate in the study
- Claustrophobia or other mental illnesses
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Z
Zhenguang Wang, Doctoral Degree
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here