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

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Colorectal Adenoma

Treatments: Device: White Light Imaging; Device: Spectral Focused Imaging

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06603948

LY2024-136-C

Details and patient eligibility

About

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

Full 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).

Enrollment: 698 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

698 participants in 2 patient groups, including a placebo group

SFI

Experimental group

Description:

Spectral Focused Imaging

Treatment:

Device: Spectral Focused Imaging

WLI

Placebo Comparator group

Description:

White Light Imaging

Treatment:

Device: White Light Imaging