68Ga-FAPI PET/CT for axillary lymph node status after neoadjuvant therapy in clinically node-positive breast cancer
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
This will see if 68Ga-FAPI PET/CT can find residual cancer in underarm (axillary) lymph nodes after neoadjuvant treatment in people with clinically node-positive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06559371 on ClinicalTrials.gov |
What this trial studies
This observational study will perform a 68Ga-FAPI PET/CT scan between the end of neoadjuvant therapy and surgery in women with pathologically confirmed breast cancer and clinically positive axillary nodes. Imaging findings will be compared with surgical and pathological nodal status to determine how well 68Ga-FAPI PET/CT detects residual axillary disease. 68Ga-FAPI PET/CT has reported advantages over 18F-FDG PET/CT such as less dependence on blood glucose and higher tumor-to-background contrast. The goal is to determine whether this imaging approach can provide an accurate, non-invasive assessment of axillary response after neoadjuvant therapy.
Who should consider this trial
Good fit: Ideal candidates are adult women (≥18) with pathologically confirmed breast cancer, clinically positive axillary nodes (cN+), ECOG 0–2, who have completed at least three courses of neoadjuvant therapy and are scheduled for surgery.
Not a fit: Patients with distant metastases, those unable to complete neoadjuvant therapy, pregnant people, or patients without clinically positive axillary nodes are unlikely to benefit from this scan for axillary staging.
Why it matters
Potential benefit: If successful, this imaging approach could provide a more accurate, non-invasive way to identify residual axillary disease and help guide surgical decisions.
How similar studies have performed: Previous studies have reported that 68Ga-FAPI PET/CT can detect some breast primary lesions and lymph node metastases with low 18F-FDG uptake and may offer higher lesion-to-background contrast than 18F-FDG PET/CT, although its role specifically for post-neoadjuvant axillary staging is still being studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 and above * ECOG score 0-2 points * Pathological confirmation of malignant breast tumor * Clinical axillary lymph node positivity (cN+) * Completed at least 3 courses of neoadjuvant therapy and subjected to undergo surgical treatment * Informed consent form signed Exclusion Criteria: * Distant metastasis * Unable to complete the proposed neoadjuvant therapy plan * Pregnancy
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Jiao Tong University School of Medicine, Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiaosong Chen — Shanghai Jiao Tong University, School of Medicine, Affiliated Ruijin Hospital
- Study coordinator: Xiaosong Chen
- Email: zsj_mu@yeah.net
- Phone: 86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.