Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Xiang-Wei Kong, Ph.D.
kongxw8@mail.sysu.edu.cn
0086-020-34071439
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 312
Treatments
Case
Histologically confirmed sbORN that meets the eligibility criteria.
Control
Histologically confirmed NPC recurrence that meets the eligibility criteria.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Sun Yat-sen University, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China

This content was sourced from clinicaltrials.gov