Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy

NCT ID: NCT05576506

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of colorectal cancer other colorectal disease by marking and analyzing the characteristics of hyperspectral images based on the pathological results of colonoscopic biopsy, so as to improve the objectiveness and intelligence of early colorectal cancer diagnosis.

Detailed Description

Prospectively collect the hyperspectral image information of ordinary colonoscopic biopsy tissue. The colonoscopic biopsy tissue is from the Endoscopy Center of Qilu Hospital of Shandong University. The hyperspectral images are marked based on the biopsy pathological results, and the deep convolutional neural network (DCNN) model is used. With training and verification, develop the Hyperspectral Imaging Artificial Intelligence Diagnostic System (HSIAIDS) .A portion of colonoscopic biopsy tissue will be collected as a prospective test set to prospectively test the diagnostic performance of the HSIAIDS algorithm.

Conditions

Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma; Colorectal SSA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Deep learning algorithm group

After the patient has passed the screening, a routine colonoscopy will be performed, and the target tissue with suspected inflammation or neoplasia will be biopsied. The clinical investigators use the hyperspectral microscope to collect image information of the biopsy tissue in the endoscopy room. After collecting information, biopsy specimens will be routinely processed and sent for pathological diagnosis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients aged 18-75 years who undergo the colonoscopy examination and biopsy

Exclusion Criteria

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in colonoscopy
• patients with previous surgical procedures on the gastrointestinal tract.
• patients with contraindications to biopsy
• patients who refuse to sign the informed consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, MD,PhD

Role: STUDY_CHAIR

Study Principal investigator

Locations

Qilu hosipital

Jinan, Shandong, China

Countries

China

Other Identifiers

2022-SDU-QILU-G003

Identifier Type: -

Identifier Source: org_study_id