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NCT Number: NCT06559371

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

Location status: Recruiting

Location contact

Chao Hu, M.D. & Ph.D.

CONTACT

[email protected]

+86 13817282551

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy

    Time frame: up to the end of surgery

    Sensitivity and specificity of 68Ga FAPI PET/CT

Secondary outcomes

  1. Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy

    Time frame: up to the end of surgery

    Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy

  2. Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy

    Time frame: up to the end of surgery

    Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy

  3. 68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy

    Time frame: From enrollment to the end of treatment at 3 years

    68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy

  4. 68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy

    Time frame: From enrollment to the end of treatment at 3 years

    68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaosong Chen

CONTACT

[email protected]

86-21-64370045

Sponsors and collaborators

Lead sponsor

Kunwei Shen

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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