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Not yet recruitingNCT06510738Updated Aug 13, 2024

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

An observational study in Breast Cancer, Artificial Intelligence and Lymph Node Metastasis, sponsored by Yunnan Cancer Hospital. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Yunnan Cancer Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
700
Ages
18 Years to 75 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Breast Cancer
  • Artificial Intelligence
  • Lymph Node Metastasis
  • Digital Pathology
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 700 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Yunnan Cancer Hospital is the lead sponsor of 28 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The investigators plan to retrospective collect 700 patients with breast cancer and prospective collect 150 patients with breast cancer

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Non-sentinel lymph node metastatic status

    metastasis or non-metastasis

    Time frame: 2024-2025

  2. Accuracy, Sensitivity, Specificity,Area under the curve

    The performance of predicting non-sentinel lymph node metastatic status

    Time frame: 2024-2025

  3. Positive predictive value,Negative predictive value

    The performance of predicting non-sentinel lymph node metastatic status

    Time frame: 2024-2025

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06510738
Lead sponsor
Yunnan Cancer Hospital
Collaborators
Affiliated Cancer Hospital of Shantou University Medical College
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Aug 2024 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 13, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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