Clinical trial · Observational
Deep Learning-based sbORN Diagnostic Model
Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Herpesvirus 4, Human | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case
- description
- Histologically confirmed sbORN that meets the eligibility criteria.
- interventionNames
- Other: No Intervention: Observational Cohort
- label
- Control
- description
- Histologically confirmed NPC recurrence that meets the eligibility criteria.
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (2)
- measure
- Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
- timeFrame
- Baseline
- measure
- Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available