18F-FAPI-04 PET scan: FAPI-04, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-FAPI-04 PET scan.
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years old, any gender;
2. Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis;
3. Presence of at least 1 measurable lesion (RECIST 1.1 criteria);
4. ECOG score 0-2 and expected survival ≥ 12 weeks;
5. 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;
6. Signed informed consent.
Exclusion Criteria:
1. Major surgery or trauma within 4 weeks;
2. Severe infection, liver or kidney insufficiency;
3. History of allergies (developer components);
4. Pregnant/nursing female or not using effective contraception;
5. Inability to co-operate with PET (e.g. claustrophobia);
6. Any other situation that researchers considered it unsuitable to participate in the trial.
Primary outcome measure(s)
SUV — 2 years The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
More The Affiliated Hospital of Qingdao University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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