Deep Learning-based sbORN Diagnostic Model

Last updated: September 27, 2024
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

No Intervention: Observational Cohort

Clinical Study ID

NCT06463392
SYSKY-2024-395-03
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Equal to or older than 18 years old.

  • A history of histologically confirmed nonkeratinizing undifferentiatednasopharyngeal 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 nasopharynxand neck.

  • With a written consent.

Exclusion

Exclusion Criteria:

  • MRI artifacts or other factors that interfere radiological diagnosis and region ofinterest contouring.

  • Suspected lesion is not confined to nasopharynx and skull-base.

Study Design

Total Participants: 312
Treatment Group(s): 1
Primary Treatment: No Intervention: Observational Cohort
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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