Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

NCT06603948 | Completed

• 1 other identifier: LY2024-136-C
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 8

Brief Summary

Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape\'s endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies. This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection

Conditions

Colorectal Adenoma

Keywords

Spectral Focused Imaging; Colorectal adenoma; ADR

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate (ADR)

  ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy

  14 days

Secondary Outcomes (20)

• Polyp Detection Rate(PDR)

  14 days

• Sessile serrated lesion detection rate (SSLDR)

  14 days

• Advanced Adenoma Detection Rate

  14 days

• Mean number of polyps per patient

  14 days

• Mean number of Adenomas per patient(MAP)

  14 days

Study Arms (2)

SFI

EXPERIMENTAL

Spectral Focused Imaging

Device: Spectral Focused Imaging

WLI

PLACEBO COMPARATOR

White Light Imaging

Device: White Light Imaging

Interventions

Spectral Focused Imaging DEVICE

Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy

SFI

White Light Imaging DEVICE

Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy

WLI

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female aged 45 to 85
• \. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
• \. Capable of providing informed consent and agreeing to participate
• \. Able and willing to follow all research processes

You may not qualify if:

• \. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
• \. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
• \. Pregnant or lactating patients;
• \. Known to have polyposis syndrome;
• \. Patients with gastrointestinal bleeding;
• \. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
• \. Patients with contraindications to tissue biopsy;
• \. History of allergies to the ingredients in intestinal cleansers;
• \. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
• \. Researchers believe that patients are not suitable to participate in the trial;
• \. Have had drug or alcohol abuse or psychological disorders in the past five years.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• First Affiliated Hospital of Ningbo University: collaborator
• Nanchong Central Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• West China Forth Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (8)

Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100700, China

Location

The People'S Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science

Wuhan, Hubei, 430000, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200000, China

Location

West China School of Public Health West China Fourth Hospital

Chengdu, Sichuan, 610000, China

Location

NanChong Center Hospital

Nanchong, Sichuan, 637000, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315020, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 25, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)