ClinicalTrials.Veeva

Menu

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

K

Kunwei Shen

Status

Enrolling

Conditions

BREAST CANCER
PET/CT

Study type

Observational

Funder types

Other

Identifiers

NCT06559371
RJBC-2403

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

68Ga-FAPI PET/CT
Description:
68Ga-FAPI PET/CT

Trial contacts and locations

1

Loading...

Central trial contact

Xiaosong Chen

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems