Deep Learning-based sbORN Diagnostic Model

NCT06463392 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase

Observational

Started

2024-07-01

Last updated

2024-10-01

Condition(s) studied

Nasopharyngeal CarcinomaHerpesvirus 4, Human

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. — Baseline
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. — Baseline

Trial sites (1)

Facility	City	Region	Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06463392 on ClinicalTrials.gov ↗ ← All trials in China