68Ga-FAPI PET/CT for axillary lymph node status after neoadjuvant therapy in clinically node-positive breast cancer
Official title: 68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
Run by Shanghai Jiao Tong University School of Medicine · NCT06559371 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 30, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT06559371 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.