Deep Learning-based sbORN Diagnostic Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Herpesvirus 4, Human

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case

Histologically confirmed sbORN that meets the eligibility criteria.

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention is scheduled for this observational study.

Control

Histologically confirmed NPC recurrence that meets the eligibility criteria.

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention is scheduled for this observational study.

Interventions

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No Intervention: Observational Cohort

No intervention is scheduled for this observational study.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No