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Age: 18Years +
FEMALE
ID06559371

68Ga FAPI PETCT 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 PETCT 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 PETCT 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 PETCT 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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis
  • Unable to complete the planned neoadjuvant therapy
  • Pregnancy

Research Team

X

Xiaosong Chen

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