Clinical trial · Interventional
Characterizing Breast Cancer With Al18F-NOTA-FAPI-04 PET/CT (PFB-02)
Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Al18F-NOTA-FAPI-04 PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Al18F-NOTA-FAPI-04 PET/CT
- description
- Inject Al18F-NOTA-FAPI-04 and then perform PET/CT scan.
- interventionNames
- Diagnostic Test: Al18F-NOTA-FAPI-04 PET/CT scan
Primary outcomes (1)
- measure
- Diagnostic Performance (1)
- timeFrame
- Through study completion, an average of 1 year
- description
- Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound.
Secondary outcomes (3)
- measure
- Clinical Stage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-80 years old; * newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG; * BC clinical stagecT1-3 cN0-3 M0; * no prior treatment for BC. Exclusion Criteria: * pregnancy; * breastfeeding; * patients who were unwilling to undergo PET/CT scans.
References
Publications (0)
Data not yet available