RecruitingNCT06463392

Deep Learning-based sbORN Diagnostic Model

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

Sponsor

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

Enrollment

312 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Nasopharyngeal Carcinoma Herpesvirus 4, Human

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops and validates an AI-based model to help diagnose skull-base osteoradionecrosis (sbORN) — a condition where bone at the base of the skull is damaged after radiation therapy for nasopharyngeal cancer — using MRI imaging data. **You may be eligible if...** - You are 18 or older - You have a history of nasopharyngeal carcinoma (a type of head and neck cancer) treated with radiation therapy - You achieved complete remission (no remaining cancer) at least 6 months after radiation - You have no evidence of cancer spread to other parts of the body - A senior radiologist has identified a suspicious lesion that may be sbORN - You are willing and able to undergo a biopsy and required blood tests and MRI scans **You may NOT be eligible if...** - Your MRI images have significant artifacts or other issues preventing accurate reading - Your suspicious lesion extends beyond the nasopharynx and skull base Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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