Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06510738
Enrollment
700
Registered
2024-07-19
Start date
2024-08-31
Completion date
2025-12-31
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Breast Cancer, Digital Pathology, Lymph Node Metastasis

Brief summary

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.

Interventions

None listed

Sponsors

Affiliated Cancer Hospital of Shantou University Medical College
CollaboratorOTHER
Yunnan Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Non-sentinel lymph node metastatic status2024-2025metastasis or non-metastasis
Accuracy, Sensitivity, Specificity,Area under the curve2024-2025The performance of predicting non-sentinel lymph node metastatic status
Positive predictive value,Negative predictive value2024-2025The performance of predicting non-sentinel lymph node metastatic status

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026