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ID06829147

Development and Validation of a Deep Learning Model for Diagnosing Lymph Node Metastasis in Nasopharyngeal Carcinoma Using Histologic Whole Slide Images and Time-dependent Magnetic Resonance Images

Led by Sun Yat-sen University · Updated on 2025-02-17

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

F

First People's Hospital of Foshan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing and validating an AI model to help diagnose lymph node metastasis in patients with nasopharyngeal carcinoma (NPC). The AI uses MRI images and pathology data to analyze single lymph nodes and surrounding areas, aiming to improve diagnosis before and after chemotherapy. This study also evaluates the AI's potential to correct past diagnoses and guide radiotherapy treatment plans, as well as its economic benefits in managing NPC. The AI model includes automatic identification and segmentation of lymph nodes and primary tumors using semi-supervised learning. It integrates MRI scans from different time points and pathological features from tumor samples to predict metastasis likelihood. The study involves retrospective analysis, validation with biopsy results in head and neck cancer patients, and prospective clinical trials to assess safety and effectiveness in guiding radiation doses. Participants will undergo MRI and PET/CT scans at diagnosis, with some having lymph node biopsies if imaging results differ. The study measures outcomes like the accuracy of diagnosis using area under the curve (AUC), sensitivity, and specificity over an average of two years. Researchers will monitor how well the AI model detects metastasis, its impact on treatment decisions, and its economic value, with participant involvement lasting throughout the study period.

CONDITIONS

Brief Title

A Deep Learning Model for Diagnosing Lymph Node Metastasis in Nasopharyngeal Carcinoma(NPC)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The primary lesion was pathologically confirmed as nasopharyngeal carcinoma (WHO classification I, II, or III)
  • MRI scans including T1-weighted, T2-weighted, and T1-enhanced sequences were performed before any anti-tumor treatment
  • PET/CT scan was performed at initial diagnosis before treatment
  • Patients agree to cervical lymph node biopsy if MRI and PET/CT results disagree on lymph node status
Not Eligible

You will not qualify if you...

  • Prior cervical lymph node radiotherapy for any reason
  • Presence of other malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to baseline before treatment

Participants undergo MRI and PET/CT scans, and may have a cervical lymph node biopsy if imaging results are unclear, to assess lymph node metastasis using AI models.

1 to 2 visits depending on imaging and biopsy requirements

Long-term Monitoring

Duration - Approximately 2 years

Participants are observed over an average of 2 years to validate the diagnostic efficacy of the AI model and monitor lymph node status.

Periodic follow-up visits as per clinical practice

Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510060

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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