Development and Validation of a Deep Learning Model to Predict Distant Metastases in Nasopharyngeal Carcinoma Using Whole Slide Imaging and MRI

Last updated: February 21, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasopharyngeal Cancer

Neoplasm Metastasis

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT06831357
B2025-062-01
  • All Genders

Study Summary

An AI model was developed to predict the likelihood of distant metastasis in patients with nasopharyngeal cancer based on pathology slides and MRI scans of the primary tumor. The model was validated using data from multiple centers. It was then applied to patients with advanced stages who were recommended to undergo PET/CT scans based on the NCCN or CSCO guidelines. This AI model can accurately screen patients with high risk of distant metastasis at the time of initial diagnosis to receive PET/CT, avoid excessive examination of patients with low risk of distant metastasis, save medical resources and reduce the economic burden on patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

A. The primary lesion was pathologically confirmed as nasopharyngeal carcinoma (WHO classification is I, II and III); B. The stage was T3-4 or N2-3, and the nasopharynx + neck MRI plain scan and enhanced scan were performed to confirm the nasopharyngeal and cervical lymph node lesions, and PET/CT or conventional examination (chest CT plain scan

  • enhanced scan, upper abdominal CT or MRI plain scan + enhanced scan or abdominal color Doppler ultrasound or ultrasound angiography, and whole body bone imaging) was performed to screen for distant metastases.

Exclusion

Exclusion Criteria:

Previous history of other malignant tumors (such as other head and neck squamous cell carcinomas, thyroid cancer, breast cancer, esophageal cancer, etc.).

Study Design

Total Participants: 500
Study Start date:
February 15, 2025
Estimated Completion Date:
December 31, 2026

Study Description

An AI model was constructed based on HE-stained pathological sections of the primary lesion and MRI of the nasopharynx and neck to predict the probability of distant metastasis at the first visit, and the AI model was fully verified by multicenter data; the AI model was applied to T3-4 or N2-3 patients who were recommended to undergo PET/CT examination according to the NCCN and CSCO guidelines, and the threshold of the AI model when the negative predictive value for predicting M0 was not less than 95% was determined, providing theoretical support for patients predicted by AI to be exempted from PET/CT examination.

Connect with a study center

  • Department of Radiation Oncology, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.