Deep learning model for diagnosing skull-base osteonecrosis in nasopharyngeal carcinoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.