Actively Recruiting
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
Led by Kunwei Shen · Updated on 2025-12-29
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether 68Ga-FAPI PET/CT scans can be a new effective way to evaluate axillary lymph nodes after neoadjuvant treatment in women with breast cancer. This observational study focuses on patients who have clinically positive axillary lymph nodes and have undergone treatment before surgery. The goal is to understand if this imaging method can better detect remaining cancer in lymph nodes compared to traditional methods. Participants will have a 68Ga-FAPI PET/CT scan after completing at least three courses of neoadjuvant therapy and before surgery. This scan is being evaluated for its ability to detect residual disease in the lymph nodes without being affected by blood glucose levels, offering potentially clearer imaging. The study will observe participants without altering their treatment, focusing on this imaging test. During the study, participants will undergo the PET/CT scan, and researchers will track how well the scan predicts residual cancer in the lymph nodes after treatment. They will measure the sensitivity and specificity of the scan up to the time of surgery, and follow participants for up to three years to see how well the scan predicts invasive disease-free survival and overall survival. Participants' usual care will continue throughout the study, which starts in August 2024 and ends in June 2026.
CONDITIONS
Brief Title
68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 and above
- ECOG score of 0 to 2 points
- Pathological confirmation of malignant breast tumor
- Clinical axillary lymph node positivity (cN+)
- Completed at least 3 courses of neoadjuvant therapy
- Scheduled to undergo surgical treatment
- Signed informed consent form
You will not qualify if you...
- Presence of distant metastasis
- Unable to complete the planned neoadjuvant therapy
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the end of surgery
Participants undergo 68Ga-FAPI PET/CT imaging to assess axillary lymph node status after completing neoadjuvant therapy.
1 visit (imaging scan)
Duration - Up to the end of surgery
Participants undergo surgical treatment following neoadjuvant therapy and imaging evaluation.
1 surgical procedure visit
Duration - From enrollment to the end of treatment at 3 years
Participants are monitored for invasive disease free survival and overall survival after neoadjuvant therapy and surgery.
Follow-up visits as per clinical schedule
Trial Site Locations
Total: 1 location
1
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
X
Xiaosong Chen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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