Actively Recruiting
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
Led by The Affiliated Hospital of Qingdao University · Updated on 2025-04-29
30
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Qingdao University
Lead Sponsor
W
Weifang People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.
CONDITIONS
Official Title
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, any gender
- Clinically or pathologically confirmed diagnosis of breast cancer or suspected recurrence/metastasis
- At least 1 measurable lesion according to RECIST 1.1 criteria
- ECOG performance status 0-2 with expected survival of at least 12 weeks
- Laboratory values: WBC ≥4.0×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; ALT/AST ≤2.5× upper limit of normal, serum creatinine ≤1.5× upper limit of normal
- Signed informed consent
You will not qualify if you...
- Major surgery or trauma within the past 4 weeks
- Severe infection or liver or kidney insufficiency
- History of allergies to study components
- Pregnant or nursing females or those not using effective contraception
- Inability to cooperate with PET scanning (e.g., claustrophobia)
- Any other condition deemed unsuitable for participation by the researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Z
Zhenguang Wang
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
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