Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
The Affiliated Hospital of Qingdao University
30 participants
Apr 11, 2025
OBSERVATIONAL
Conditions
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 Criteria7
- 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 Criteria6
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06916338