Deep learning model for diagnosing skull-base osteonecrosis in nasopharyngeal carcinoma patients
Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model
This study is testing a new computer program to see if it can better diagnose a serious condition called skull-base osteonecrosis in people who have had treatment for nasopharyngeal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 312 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06463392 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a deep learning-based diagnostic model for skull-base osteonecrosis (sbORN), a serious complication following radiotherapy for nasopharyngeal carcinoma (NPC). The study will recruit 312 participants from Sun Yat-sen Memorial Hospital in Guangzhou, China, who have a history of NPC and meet specific eligibility criteria. The goal is to determine if the deep learning model can achieve higher sensitivity in diagnosing sbORN compared to traditional radiologist assessments. Participants will undergo various diagnostic procedures, including MRI and blood tests, to support the evaluation of the model's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of nonkeratinizing undifferentiated nasopharyngeal carcinoma who have undergone radical radiotherapy and are in complete remission.
Not a fit: Patients with MRI artifacts or lesions not confined to the nasopharynx and skull-base may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of skull-base osteonecrosis, improving patient outcomes and quality of life.
How similar studies have performed: While the use of deep learning in medical diagnostics is gaining traction, this specific application for diagnosing sbORN in NPC patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiang-Wei Kong, Ph.D.
- Email: kongxw8@mail.sysu.edu.cn
- Phone: 0086-020-34071439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.