Deep Learning-based sbORN Diagnostic Model (NCT06463392) | Clinical Trial Compass
RecruitingNot Applicable
Deep Learning-based sbORN Diagnostic Model
China312 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Timeframe: Baseline
2
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Timeframe: Baseline
Trial details
NCT IDNCT06463392
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University