Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer

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

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.

Conditions2

Browse More Trials