Status:
RECRUITING
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Weifang People's Hospital
Zibo Central Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
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 fibro...
Detailed Description
Breast cancer diagnosis and treatment continue to face challenges in adequately assessing tumor heterogeneity and dynamically monitoring therapeutic responses. Traditional biopsy-dependent pathologica...
Eligibility Criteria
Inclusion
- Age 18-75 years old, any gender;
- Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis;
- Presence of at least 1 measurable lesion (RECIST 1.1 criteria);
- ECOG score 0-2 and expected survival ≥ 12 weeks;
- Laboratory markers are met:
- Blood count: WBC ≥4.0×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L Liver and kidney function: ALT/AST ≤ 2.5 × ULN, SCr ≤ 1.5 × ULN;
- Signed informed consent.
Exclusion
- Major surgery or trauma within 4 weeks;
- Severe infection, liver or kidney insufficiency;
- History of allergies (developer components);
- Pregnant/nursing female or not using effective contraception;
- Inability to co-operate with PET (e.g. claustrophobia);
- Any other situation that researchers considered it unsuitable to participate in the trial.
Key Trial Info
Start Date :
April 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06916338
Start Date
April 11 2025
End Date
December 1 2027
Last Update
April 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000