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

NCT06559371 | Recruiting DMC

• 1 other identifier: RJBC-2403
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BREAST CANCER; PET/CT

Keywords

BREAST CANCER; PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  up to the end of surgery

• 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

  From enrollment to the end of treatment at 3 years

Study Arms (1)

68Ga-FAPI PET/CT

68Ga-FAPI PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Distant metastasis
• Unable to complete the proposed neoadjuvant therapy plan
• Pregnancy

Sponsors & Collaborators

• Kunwei Shen: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaosong Chen

  Shanghai Jiao Tong University, School of Medicine, Affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaosong Chen

CONTACT

86-21-64370045; zsj_mu@yeah.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)