68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer

The goal of this observational study is to learn whether 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. The main question it aims to answer is:

Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.

Study Overview

• Status: Recruiting
• Conditions: PET/CT; BREAST CANCER

Detailed Description

Previous studies have shown that compared with conventional 18F-FDG PET/CT, 68Ga-FAPI PET/CT has the characteristics of not being affected by blood glucose, good tumor specificity, and high tumor-to-background ratio, and studies have shown that 68Ga- FAPI PET/CT can detect parts of breast cancer primary lesions and lymph node metastases with low 18F-FDG uptake, thereby increasing the lesion detection rate and improving the sensitivity of imaging examinations. Therefore, 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. Therefore, we plan to conduct this study to explore the ability of 68Ga-FAPI PET/CT to detect residual disease in axillary lymph nodes in patients with clinically positive axillary node (cN+) breast cancer after neoadjuvant treatment. By this way, we may explore an accurate and non-invasive assessment of axillary lymph node status after neoadjuvant therapy in breast cancer patients.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Xiaosong Chen; Phone Number: 86-21-64370045; Email: zsj_mu@yeah.net

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200020
      • Recruiting
      • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
      • Contact: Chao Hu, M.D. & Ph.D.; Phone Number: +86 13817282551; Email: chaohu1988@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
68Ga-FAPI PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy	Sensitivity and specificity of 68Ga FAPI PET/CT	up to the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy	Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy	up to the end of surgery
Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy	Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy	up to the end of surgery
68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy	68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy	From enrollment to the end of treatment at 3 years
68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy	68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy	From enrollment to the end of treatment at 3 years

Collaborators and Investigators

• Sponsor: Kunwei Shen
• Investigators: Principal Investigator: Xiaosong Chen, Shanghai Jiao Tong University, School of Medicine, Affiliated Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PET/CT; BREAST CANCER
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: RJBC-2403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No