Deep Learning-based sbORN Diagnostic Model
Recruiting
- Conditions
- Herpesvirus 4, HumanNasopharyngeal Carcinoma
- Registration Number
- NCT06463392
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 312
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline
- Secondary Outcome Measures
Name Time Method Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. Baseline Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists. Baseline Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists. Baseline Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists. Baseline
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China