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To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04547673
Enrollment
1000
Registered
2020-09-14
Start date
2020-06-20
Completion date
2026-12-31
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Otolaryngological Disease

Keywords

Nasopharyngeal Carcinoma, Endoscopy, Narrow-Band Imaging, White-Light Imaging

Brief summary

Nasopharyngeal carcinoma (NPC) occurs at a high frequency in southern China, northern Africa, and Alaska, with a reported incidence of 30 cases per 100 000 in Guangdong Province. Endoscopic examination and biopsy are the main methods used for detection and diagnosis of NPC. Early NPC patients achieve favourable prognoses after concurrent radiotherapy and chemotherapy in compassion with advanced NPC patients. Here, the investigators focused on the utility of artificial intelligence to detect early NPC, which based on white light imaging (WLI) and Narrow-band imaging (NBI) nasoendoscopic examination. Having access to this unique population provides an unprecedented opportunity to investigate the effect of intelligent system on diverse nasopharyngeal lesions detection and develop a novel Computer-Aided Diagnosis System.

Interventions

DIAGNOSTIC_TESTrigid nasal endoscopes

The endoscope is introduced through the nasal passage to observe, in sequence, the posterior nostril, superior and posterior walls of the nasopharynx, torus tubarius, pharyngeal opening of the auditory tube, and Rosenmu¨ller recess. The imaging light mode is set to conventional WLI and subsequently switch to NBI during the procedure, and representative images are collected and preserve for further analysis. All lesions, detected by either WLI or NBI, are biopsied.

Sponsors

Sun Yat-sen University
CollaboratorOTHER
First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Older than 18 years of age

Exclusion criteria

* Refuse to sign the informed consent statement * Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.

Design outcomes

Primary

MeasureTime frameDescription
Pathological diagnosisbaselineAll lesions, detected by either WLI or NBI, are biopsied. 2 experienced pathologists, who were blinded to the endoscopic and intelligent assessment, evaluate the pathological nature of the biopsied lesion independently, and 2 professors with over 10 years of experience in Otolaryngology and pathology department are consulted in cases of disagreement.

Secondary

MeasureTime frameDescription
Lesion rangebaselineAll images in which lesions are pathologically diagnosed as NPC are collected. 2 experienced pathologists, who were blinded to the endoscopic and intelligent assessment, delineated the malignant area in the images independently, and 2 professors with over 10 years of experience in Otolaryngology department are consulted in cases of disagreement.

Countries

China

Contacts

Primary ContactYihui Wen, Ph.D
wenyihui@mail.sysu.edu.cn+86-13480200660
Backup ContactRui He, M.D.
herui27@mail2.sysu.edu.cn13096385286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026