- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335654
Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms
April 16, 2024 updated by: Hong Xu, The First Hospital of Jilin University
Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms: a Single Center, Prospective Clinical Study
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide.
Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer.
In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically.
However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year.
In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy.
The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy.
Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC.
Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions.
The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x.
EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode.
However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy.
Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis.
There is an artificial intelligence system which has been developed to identify colorectal neoplasms.
However, there is still a lack of prospective clinical verification based on Chinese population.
In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mingqing Liu, Doctor
- Phone Number: +8613204300453
- Email: liumq23@mails.jlu.edu.cn
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- Recruiting
- First Hospital of Jilin 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The investigators analyzed only endoscopically or surgically resected colorectal lesions that had been observed with EC-NBI and EC-stained by endoscopists and artificial intelligence system before treatment that were ultimately performed histopathologic examination.
Description
Inclusion Criteria:
- colorectal lesions
Exclusion Criteria:
- non-epithelial tumors
- a history of inflammatory bowel disease
- chemotherapy or radiation therapy for colorectal cancer
- lesions without clear EC images
- specific pathological types
- familial adenomatous polyposis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
colorectal lesion
|
The colorectal lesions had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination.
The endocytoscopies (CF-H290ECI, Olympus, Tokyo, Japan) have a maximum magnification of ×520, focusing depth, 35 μm; field of view, 570 × 500μm.
During EC-NBI , the endoscopist pushed the button of the endoscope to switch from white-light imaging to NBI and observed the lesion with full magnification.
After endocytoscopic observation, the artificial intelligence system will be open and display the predictive result.
Finally, the endoscopist performed EC-stained mode diagnosis after staining the lesion surface with 1.0% methylene blue.
After endocytoscopic observation, the artificial intelligence system will be open again and display the predictive result.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sensitivity
Time Frame: December 2024
|
December 2024
|
specificity
Time Frame: December 2024
|
December 2024
|
accuracy
Time Frame: December 2024
|
December 2024
|
positive predictive value
Time Frame: December 2024
|
December 2024
|
negative predictive value
Time Frame: December 2024
|
December 2024
|
high confidence diagnosis rate
Time Frame: December 2024
|
December 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 22, 2024
First Submitted That Met QC Criteria
March 22, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24K056-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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