Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection (SFI verus WLI)

June 28, 2025 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine

Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China).

The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Study Type

Interventional

Enrollment (Actual)

698

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China School of Public Health West China Fourth Hospital
      • Nanchong, Sichuan, China, 637000
        • NanChong Center Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • The First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315020
        • The First Affiliated Hospital Of Ningbo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
  • 2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
  • 3. Pregnant or lactating patients;
  • 4. Known to have polyposis syndrome;
  • 5. Patients with gastrointestinal bleeding;
  • 6. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
  • 7. Patients with contraindications to tissue biopsy;
  • 8. History of allergies to the ingredients in intestinal cleansers;
  • 9. 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.
  • 10. Researchers believe that patients are not suitable to participate in the trial;
  • 11. Have had drug or alcohol abuse or psychological disorders in the past five years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SFI
Spectral Focused Imaging
Device: Spectral Focused Imaging
Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
Placebo Comparator: WLI
White Light Imaging
Device: White Light Imaging
Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate (ADR)
Time Frame: 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp Detection Rate(PDR)
Time Frame: 14 days
Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.
14 days
Sessile serrated lesion detection rate (SSLDR)
Time Frame: 14 days
SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy
14 days
Advanced Adenoma Detection Rate
Time Frame: 14 days
Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.
14 days
Mean number of polyps per patient
Time Frame: 14 days
Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.
14 days
Mean number of Adenomas per patient(MAP)
Time Frame: 14 days
Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Polyps of Different Sizes
Time Frame: 14 days
It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Adenomas with Different Morphologies
Time Frame: 14 days
It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.
14 days
Average Number of Adenomas with Different Morphologies
Time Frame: 14 days
It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.
14 days
Average Number of Polyps of Different Sizes
Time Frame: 14 days
It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Adenomas of Different Sizes
Time Frame: 14 days
It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.
14 days
Average Number of Adenomas of Different Sizes
Time Frame: 14 days
It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Adenomas in Different Locations
Time Frame: 14 days
It is calculated by dividing the number of patients with detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
14 days
Average Number of Adenomas in Different Locations
Time Frame: 14 days
It is calculated by dividing the number of detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Polyps in Different Locations
Time Frame: 14 days
It is calculated by dividing the number of patients with detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
14 days
Average Number of Polyps in Different Locations
Time Frame: 14 days
It is calculated by dividing the number of detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
14 days
Detection Rate of Polyps with Different Morphologies
Time Frame: 14 days
It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.
14 days
Average Number of Polyps with Different Morphologies
Time Frame: 14 days
It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.
14 days
Insertion Time of Colonoscopy
Time Frame: 14 days
The time taken from the rectum to the cecum.
14 days
Withdrawal Time of Colonoscopy
Time Frame: 14 days
The time taken to complete the examination starting from the cecum.
14 days
Cecal Intubation Rate
Time Frame: 14 days
It is calculated by dividing the number of colonoscopies that reach the cecum by the total number of colonoscopies performed.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Tongji Hospital
First Affiliated Hospital of Xinjiang Medical University
Nanchong Central Hospital
Seventh Medical Center of PLA Army General Hospital
First Affiliated Hospital of Ningbo University
West China Forth Hospital
People's Hospital of Guangxi Zhuang Autonomous Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

June 25, 2025

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-136-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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