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

NCT ID: NCT06559371

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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BREAST CANCER PET/CT

Keywords

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BREAST CANCER PET/CT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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68Ga-FAPI PET/CT

68Ga-FAPI PET/CT

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kunwei Shen

OTHER

Sponsor Role lead

Responsible Party

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Kunwei Shen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaosong Chen

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaosong Chen

Role: CONTACT

Phone: 86-21-64370045

Email: [email protected]

Facility Contacts

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

Role: primary

Other Identifiers

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RJBC-2403

Identifier Type: -

Identifier Source: org_study_id