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Recruiting NCT06463392

Deep Learning-based sbORN Diagnostic Model

— Observational Nasopharyngeal Carcinoma Herpesvirus 4, Human

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma, Herpesvirus 4, Human. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model

Overview

Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.

Interventions

  • Other No Intervention: Observational Cohort
    No intervention is scheduled for this observational study.

Primary outcome measures

  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
Secondary outcome measures (12)
  • Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. [Time frame: Baseline]
  • Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
  • Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
  • F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
  • Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
  • Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. [Time frame: Baseline]
  • Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists. [Time frame: Baseline]
  • Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Equal to or older than 18 years old.
  • A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.
  • A history of radical radiotherapy at nasopharynx.
  • Complete remission six months post radical radiotherapy according to RECIST 1.1.
  • No evidence of distant metastasis upon recruitment.
  • Diagnosis of sbORN given by senior radiologist with 2-4 Likert scores.
  • Consent to biopsy awake or under general anesthesia.
  • Consent to perform blood tests, EBV DNA, EBV IgAs, and MRI inspection of nasopharynx and neck.
  • With a written consent.

Exclusion criteria

  • MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.
  • Suspected lesion is not confined to nasopharynx and skull-base.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT06463392 · SYSKY-2024-395-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗