Deep Learning-based sbORN Diagnostic Model

Sun Yat-sen University

Status

Enrolling

Conditions

Herpesvirus 4, Human

Nasopharyngeal Carcinoma

Treatments

Other: No Intervention: Observational Cohort

Study type

Observational

Funder types

Other

Identifiers

NCT06463392

SYSKY-2024-395-03

Details and patient eligibility

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.

Enrollment

312 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.