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NCT Number: NCT06831357

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

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

Treatment and study plan

Primary outcomes

  1. Negative predictive value

    Time frame: through study completion, an average of 2 year

    NPV measures the proportion of predicted negative cases that are actually negative. It tells us how reliable the model is when it predicts a negative outcome.

Secondary outcomes

  1. Sensitivity, specificity, and positive predictive value

    Time frame: through study completion, an average of 2 year

    Sensitivity, specificity, and positive predictive value of AI in predicting distant metastasis at the threshold corresponding to a negative predictive value of 95%.

Study contacts

Contact information is provided by the study sponsor or research team.

Pu-Yun OuYang

CONTACT

[email protected]

+8618565382769

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Qingyuan People's Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The Affiliated Panyu Center Hospital of Guangzhou Medical University

Registry information

Official study title

Development and Multicenter Validation of a Deep Learning Model Based on Whole Slide Imaging and Magnetic Resonance Imaging of the Nasopharynx and Lymph Nodes to Predict Distant Metastases at Diagnosis in Nasopharyngeal Carcinoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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