Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images

NCT ID: NCT06510738

Last Updated: 2024-08-13

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

NOT_YET_RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-12-31

Brief Summary

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The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:

Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?

Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?

Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?

Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.

Detailed Description

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Conditions

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Breast Cancer Artificial Intelligence Lymph Node Metastasis Digital Pathology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients with primary breast cancer
2. Positive sentinel lymph node biopsy and axillary lymph node dissection.
3. No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
4. MRI within 3 weeks prior to surgery.

Exclusion Criteria

1. recurrent breast cancer or history of surgery or radiation therapy in the axilla
2. Inflammatory breast cancer
3. Bilateral breast cancer or metastatic breast cancer
4. previous or current history of other malignant tumors
5. Sentinel lymph node count \> 5
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Cancer Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KYLX2024-128

Identifier Type: -

Identifier Source: org_study_id

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