Deep Learning-based sbORN Diagnostic Model

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jun 12, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Deep Learning-based sbORN Diagnostic Model" is studying a condition called skull-base osteonecrosis (sbORN), which can occur in patients who have received treatment for nasopharyngeal carcinoma (NPC). This condition can lead to serious complications that affect a person's quality of life, making it essential to diagnose it accurately. The researchers want to find out if a new deep-learning model can identify sbORN more effectively than traditional radiologists. They plan to recruit 312 participants from Sun Yat-sen Memorial Hospital in Guangzhou, China, to see how well this new tool works.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed history of nonkeratinizing undifferentiated nasopharyngeal carcinoma, along with having undergone radical radiotherapy. They must be in complete remission for at least six months and show no signs of cancer spreading to other parts of the body. Those who join the study can expect to undergo various tests, including blood tests and MRI scans, and will need to agree to a biopsy. This trial is currently recruiting participants, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.