Actively Recruiting
Deep Learning-based sbORN Diagnostic Model
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-10-01
312
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Deep Learning-based sbORN Diagnostic Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma
- History of radical radiotherapy at nasopharynx
- Complete remission for at least six months post-radiotherapy according to RECIST 1.1
- No evidence of distant metastasis at recruitment
- Diagnosis of skull-base osteonecrosis by senior radiologist with 2-4 Likert scores
- Consent to biopsy under awake or general anesthesia
- Consent to blood tests, EBV DNA and IgA tests, and MRI of nasopharynx and neck
- Written informed consent provided
You will not qualify if you...
- MRI artifacts or other factors that interfere with radiological diagnosis and region of interest contouring
- Suspected lesion not confined to nasopharynx and skull-base
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xiang-Wei Kong, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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