Colorectal AdenomaSFI verus WLINCT06603948
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection
A study testing Spectral Focused Imaging and White Light Imaging in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 8 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Spectral Focused Imaging and White Light Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 698 participants
- Where
- 8 sitesChina
- Study dates
- 7 Oct 2024to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100700
West China School of Public Health West China Fourth Hospital
Chengdu, Sichuan, 610000
NanChong Center Hospital
Nanchong, Sichuan, 637000
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science
Wuhan, Hubei, 430000
About this study
Official title: 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
Read the 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).
- Conditions
- Colorectal Adenoma
- Being tested
- Spectral Focused Imaging, White Light Imaging
- Keywords
- Spectral Focused Imaging, Colorectal adenoma, ADR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral Focused ImagingDevice
Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
White Light ImagingDevice
Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| SFI | Experimental | Spectral Focused Imaging Receives: Device: Spectral Focused Imaging |
| WLI | Placebo comparator | White Light Imaging Receives: Device: White Light Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (20)
Polyp Detection Rate(PDR)
Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.
Measured: 14 days
Sessile serrated lesion detection rate (SSLDR)
SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy
Measured: 14 days
Advanced Adenoma Detection Rate
Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.
Measured: 14 days
Mean number of polyps per patient
Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.
Measured: 14 days
Mean number of Adenomas per patient(MAP)
Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Polyps of Different Sizes
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.
Measured: 14 days
Detection Rate of Adenomas with Different Morphologies
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.
Measured: 14 days
Average Number of Adenomas with Different Morphologies
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.
Measured: 14 days
Average Number of Polyps of Different Sizes
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.
Measured: 14 days
Detection Rate of Adenomas of Different Sizes
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.
Measured: 14 days
Average Number of Adenomas of Different Sizes
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.
Measured: 14 days
Detection Rate of Adenomas in Different Locations
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.
Measured: 14 days
Average Number of Adenomas in Different Locations
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.
Measured: 14 days
Detection Rate of Polyps in Different Locations
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.
Measured: 14 days
Average Number of Polyps in Different Locations
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.
Measured: 14 days
Detection Rate of Polyps with Different Morphologies
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.
Measured: 14 days
Average Number of Polyps with Different Morphologies
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.
Measured: 14 days
Insertion Time of Colonoscopy
The time taken from the rectum to the cecum.
Measured: 14 days
Withdrawal Time of Colonoscopy
The time taken to complete the examination starting from the cecum.
Measured: 14 days
Cecal Intubation Rate
It is calculated by dividing the number of colonoscopies that reach the cecum by the total number of colonoscopies performed.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Oct 2024
- Primary completion30 Apr 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Ningbo University, Nanchong Central Hospital, First Affiliated Hospital of Xinjiang Medical University, West China Fourth Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Seventh Medical Center of PLA Army General Hospital, Tongji Hospital
- Responsible party
- Principal investigator, Xiaobo Li, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603948
- Sponsor's protocol ID
- LY2024-136-C
- Acronym
- SFI verus WLI
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang QW, Liao J, Zeng X, Yi N, Li N, Zhang T, Liu M, Ye G, Yao P, Chou J, Hu C, Li XB. Spectral focused imaging enables enhanced colorectal adenoma detection: a multicenter, parallel randomized controlled trial. BMC Med. 2026 Jun 8. doi: 10.1186/s12916-026-04977-8. Online ahead of print.
PubMed 42260471
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06603948
- Acronym / sponsor ID
- SFI verus WLI / LY2024-136-C
- Conditions
- Colorectal Adenoma
- Keywords
- Spectral Focused Imaging, Colorectal adenoma, ADR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Ningbo University, Nanchong Central Hospital, First Affiliated Hospital of Xinjiang Medical University, West China Fourth Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Seventh Medical Center of PLA Army General Hospital, Tongji Hospital
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFI | Experimental | Device: Spectral Focused ImagingSpectral Focused Imaging |
| WLI | Placebo comparator | Device: White Light ImagingWhite Light Imaging |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectral Focused ImagingUse of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy | Device | SFI |
| White Light ImagingUse of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy | Device | WLI |
Primary outcome
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
20 secondary outcomes
Polyp Detection Rate(PDR)
Time frame: 14 days
Sessile serrated lesion detection rate (SSLDR)
Time frame: 14 days
Advanced Adenoma Detection Rate
Time frame: 14 days
Mean number of polyps per patient
Time frame: 14 days
Mean number of Adenomas per patient(MAP)
Time frame: 14 days
Detection Rate of Polyps of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas with Different Morphologies
Time frame: 14 days
Average Number of Adenomas with Different Morphologies
Time frame: 14 days
Average Number of Polyps of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas of Different Sizes
Time frame: 14 days
Average Number of Adenomas of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas in Different Locations
Time frame: 14 days
Average Number of Adenomas in Different Locations
Time frame: 14 days
Detection Rate of Polyps in Different Locations
Time frame: 14 days
Average Number of Polyps in Different Locations
Time frame: 14 days
Detection Rate of Polyps with Different Morphologies
Time frame: 14 days
Average Number of Polyps with Different Morphologies
Time frame: 14 days
Insertion Time of Colonoscopy
Time frame: 14 days
Withdrawal Time of Colonoscopy
Time frame: 14 days
Cecal Intubation Rate
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 42260471Zhang QW, Liao J, Zeng X, Yi N, Li N, Zhang T, Liu M, Ye G, Yao P, Chou J, Hu C, Li XB. Spectral focused imaging enables enhanced colorectal adenoma detection: a multicenter, parallel randomized controlled trial. BMC Med. 2026 Jun 8. doi: 10.1186/s12916-026-04977-8. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral Focused Imaging and White Light Imaging in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (ADR) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06603948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.