Development and Validation of an AI Model Using MRI and Pathology to Diagnose Lymph Node Spread in Nasopharyngeal Cancer
Led by Sun Yat-sen University · Updated on 2025-02-17
500
Participants Needed
1
Research Sites
N/A
Total Duration
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 AIs 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 PETCT 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)
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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
You will not qualify if you...
Prior cervical lymph node radiotherapy for any reason
Presence of other malignant tumors
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
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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