An observational study in Breast Cancer, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Peking Union Medical College Hospital · Observational
Axillary lymph node (ALN) status is a crucial prognostic factor in breast cancer. Accurate, non-invasive methods for evaluating axillary lymph node metastasis after neoadjuvant therapy (NAT) are needed to optimize surgical decisions and minimize patient morbidity. Fibroblast Activation Protein Inhibitor (FAPI) PET/CT targets cancer-associated fibroblasts and may improve diagnostic accuracy. This study aims to assess the diagnostic performance and clinical utility of 18F-FAPI PET/CT in detecting ALN metastasis after NAT in breast cancer patients. This prospective, single-center study will enroll breast cancer patients with cT1-4N0-1M0 stage before NAT, who will undergo pre-surgical 18F-FAPI PET/CT followed by sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) guided by protocol stratification based on FAPI PET/CT and clinical findings. The primary endpoint is the diagnostic accuracy of 18F-FAPI PET/CT for ALN metastasis versus pathology. Secondary endpoints include false-negative rates (FNR) of SLNB, lymphedema rates, and long-term outcomes such as local recurrence and survival rates.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 172 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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This study is designed as a single-center, prospective observational diagnostic accuracy trial. It will be conducted at the Department of Breast Sugery and Nuclear Medicine of PUMCH, Beijing, China, between June 2025 and May 2027. The study population consists of stage cT1-4N0-1M0 breast cancer patients with who received NAT (Fig. 1). After completion of NAT, surgical approach (ALND/SLNB) is guided by protocol stratification based on 18F-FAPI PET/CT and clinical findings. There is no randomization in this study, and all enrolled patients will undergo the index test and the reference standard surgical evaluation.
Exclusion Criteria:
If clinical exam and 18F-FAPI PET/CT are positive for ALN involvement both before and after NAT, the patient proceeds directly to ALND as per standard guidelines.
If clinically/pathologically node-positive (c/pN1) pre-NAT but becomes clinically and 18F-FAPI PET/CT negative post-NAT, the patient undergoes ALND as per standard guidelines. However, within this ALND procedure, sentinel lymph nodes (SLNs) will be identified and sent separately for pathological analysis to assess the FNR of FAPI-PET guided SLNB evaluation in this specific scenario, without additional trauma or cost to the patient.
Includes two subgroups: (a) Patients who were clinically/pathologically node-negative pre-NAT and remain clinically and 18F-FAPI PET/CT negative post-NAT. (b) Patients who were clinically node-negative pre- and post-NAT, but 18F-FAPI-PET/CT becomes positive post-NAT. Within Cohort 3, management depends on patient preference: either proceed directly to ALND or undergo SLNB first (using dual tracer). If SLNB is positive, completion ALND follows; if negative, ALND is omitted. Dual tracer methods include methylene blue, contrast-enhanced ultrasound, or radionuclide imaging.
diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT
The primary endpoint of the study is the diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT, on a patient-level analysis. This will be assessed by calculating: i)Sensitivity: proportion of patients with pathologically proven residual nodal metastasis who had a positive 18F-FAPI PET/CT (true positive rate). ii)Specificity: proportion of patients with no residual nodal metastasis (pathologic nodal pCR) who had a negative PET/CT (true negative rate). iii)Positive predictive value (PPV): probability that a PET-positive patient truly has nodal disease on pathology. iv)Negative predictive value (NPV): probability that a PET-negative patient is truly node-negative on pathology. v)Overall accuracy: proportion of all patients correctly classified by PET (true positives + true negatives divided by total).
Time frame: Through study completion, an average of 3 years.
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Plan to share: No
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Peking Union Medical College Hospital