Comparing new imaging technology to standard methods for detecting colorectal adenomas

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

This study is testing a new imaging technology called Spectral Focused Imaging to see if it can find more colorectal adenomas during colonoscopy compared to the standard method for people aged 45 to 85 who are having their first colonoscopy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (other)
• Locations: 12 sites (Beijing, Beijing and 11 other locations)
• Trial ID: NCT06603948 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Spectral Focused Imaging (SFI) compared to traditional White Light Imaging (WLI) in detecting colorectal adenomas during colonoscopy. Participants aged 45 to 85, undergoing their first colonoscopy, are randomly assigned to receive either SFI or WLI. The study aims to determine if SFI can improve the adenoma detection rate (ADR) by enhancing the visibility of colonic mucosal vessels. The trial is multicenter and utilizes high-definition endoscopes to ensure accurate results.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 45 to 85 undergoing their first colonoscopy for screening or due to gastrointestinal symptoms.

Not a fit: Patients with a history of polyposis syndrome, inflammatory bowel disease, or colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved detection rates of colorectal adenomas, potentially reducing the incidence of colorectal cancer.

How similar studies have performed: While data on SFI is limited, preliminary studies suggest it may enhance adenoma detection, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 11 other locations

• Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital — Beijing, Beijing, China (RECRUITING)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (RECRUITING)
• Fujian Provincial Hospital — Fuzhou, Fujian, China (RECRUITING)
• The People'S Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (RECRUITING)
• Lingshan County People's Hospital — Qinzhou, Guangxi, China (RECRUITING)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science — Wuhan, Hubei, China (RECRUITING)
• The First Affiliated Hospital of Yichun University/The people's Hospital of Wanzai County — Yichun, Jiangxi, China (RECRUITING)
• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (RECRUITING)
• West China School of Public Health West China Fourth Hospital — Chengdu, Sichuan, China (RECRUITING)
• NanChong Center Hospital — Nanchong, Sichuan, China (RECRUITING)
• The First Affiliated Hospital of Xinjiang Medical University — Urumqi, Xinjiang, China (RECRUITING)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Qing-Wei Zhang, MD

Conditions: Colorectal Adenoma, Spectral Focused Imaging, Colorectal adenoma, ADR