- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236594
Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases (Endo-mmfi)
January 24, 2024 updated by: Beijing 302 Hospital
We plan the study to explore the application of endoscopic laser speckle imaging and multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the differences in the morphology, density and functional status of mucosal surfaces and deep blood vessels of different gastrointestinal lesions, also to explore the role of endoscopic multimodal functional imaging in common gastrointestinal diseases, especially in the early diagnosis of gastrointestinal tumors.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The current focus of electronic endoscopy is on the morphology and fine structure of the mucosal surface, and there is no effective observation method for the deep structure of the mucosa and the function of blood oxygen binding.
However, the multilayer morphology and functions of mucosal vessels under different conditions of digestive tract lesions should be different.
Therefore, we propose a method of endoscopic multimodal functional imaging to the conventional endoscopic examinations observing the mucosa of the digestive tract, which is based on the existing electronic endoscope, laser speckle contrast imaging and multispectral blood oxygen imaging technology.
Laser irradiation was given to obtain the information of coherent light on the mucosal surface and deep scattering of coherent light to obtain multi-level vascular distribution information, and multispectral irradiation imaging was carried out to obtain the oxygenation situation of the mucosa.
Finally, we may find the differences of images of deep blood vessels among common gastrointestinal diseases, which could help us to make early diagnosis of gastrointestinal tumors noninvasively.
Study Type
Observational
Enrollment (Estimated)
100
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: Wei Shen
- Phone Number: +8615001038695
- Email: shshenw@sina.com
Study Contact Backup
- Name: Shujuan Li
- Phone Number: +8601066947300
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Recruiting
- The Fifth medical center of Chinese PLA General Hospital
-
Principal Investigator:
- Yan Liu
-
Contact:
- Wei Shen
- Phone Number: +8615001038695
- Email: shshenw@sina.com
-
Contact:
- Shujuan Li
- Phone Number: +8601066947300
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Meet the inclusion and exclusion criteria.
Description
Inclusion Criteria:
- Age: 18-80 years old, gender is not limited
- Diagnosed or suspected of one of the following common gastrointestinal mucosal diseases: Chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, early gastric cancer, advanced gastric cancer, colon polyps, colon melanosis, inflammatory bowel disease, early colon cancer, advanced colon cancer
- Sign the informed consent form -
Exclusion Criteria:
- Combined with cardiovascular and cerebrovascular diseases, or severe impairment of liver, kidney and hematopoietic system;
- mentally ill;
- the presence of bleeding disorders;
- Platelet count<50×10^9/L;
- Inability to tolerate or cooperate with endoscopy;
- Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction, perforation, etc.;
- Pregnant or lactating women.
- Refuse to sign the informed consent form
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality rate
Time Frame: one year
|
The main evaluation index (image quality rate) is based on FAS(Full Analysis Set) and PPS(Per Protocol Set), for statistical description.
Image quality rate Calculation formula: image excellent rate = number of cases with excellent or good image quality evaluation ÷ number of subjects undergoing multimodal endoscopy × 100%.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis accuracy according to image
Time Frame: one year
|
(1) Endoscopy examinations combined with laser speckle imaging and Doppler blood oxygen imaging can realize multi-level vascular observation and photographing of the mucosa, and the imaging analyzer will analyzes and synthesizes the two-dimensional map of laser speckle and blood oxygen imaging of the mucosa.
Endoscopist will make diagnosis according to the image they get.
(2) After endoscopic biopsy or endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESD) obtaining tissue specimens, the pathology was observed by conventional HE staining or immunohistochemistry. (3) The results of comparison are divided into conformity, partial conformity and non-conformity.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yan Liu, Beijing 302 Hospital
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)
September 18, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 24, 2024
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Actual)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- multimodal endoscopic imaging
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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