Clinical Validation of Multimodal Digestive Endoscopy

March 27, 2025 updated by: Kaichun Wu, Xijing Hospital of Digestive Diseases

Clinical Validation of Multimodal Digestive Endoscopy in the Diagnosis of Colorectal Lesions

According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. The 5-year survival rate for early CRC can reach 90%, while less than 14% for advanced CRC. Therefore, early diagnosis of CRC is particularly important. Gastrointestinal (GI) endoscopy is an important method in the diagnosis of CRC. Currently, diagnosis of GI endoscopy is mainly based on morphological changes of tumors, while early-stage tumors are difficult to be detected because of the indistinguishable morphology. Studies have shown that the molecular function of cancer cells can be altered in early-stage tumors. The development of a new endoscopic system that can identify early tumor molecular function changes and improve the accuracy of morphological diagnosis will greatly improve the early diagnosis rate of CRC, which is the future direction of GI endoscopic system design and development.

The combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) is ideal for future new GI endoscopy. High-definition white light endoscopy is helpful to quickly find and locate suspected abnormal mucosa; on top of this, ECLI enables molecule-specific functional imaging for accurate identification and determination of GI lesions; and further relies on pCLE for high-precision "cellular-level" lesion images for optical biopsy of lesions. Through the multimodal digestive endoscopy, structural imaging and functional imaging can be accomplished simultaneously, playing the innate advantage of multimodal information fusion diagnosis and facilitating the identification of early-stage tumors.

In this clinical trial, patients with colorectal lesions who underwent PET-CT in Xijing Hospital were enrolled. Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's colorectal lesion. ECLI images were compared with PET-CT images, and pCLE images were compared with lesion histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital

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

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

grade III A hospital

Description

Inclusion Criteria:

  1. Age >18 years old.
  2. Clinical diagnosis of colorectal cancer, colorectal polyps, colorectal adenomas and enteritis.
  3. No allergy to relevant imaging agents.
  4. Person who is able to understand and sign the informed consent form.
  5. Person who is willing to participate in this experiment.

Exclusion Criteria:

  1. Patient who has been treated for colorectal lesions (endoscopic treatment, surgery , targeted therapy, and radiotherapy, etc.)
  2. Patients with severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, or nervous system.
  3. Women who are pregnant or breastfeeding.
  4. Person without personal freedom and independent civil capacity.

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
Patients with a clinical diagnosis of colorectal cancer, colorectal polyps, and colorectal adenomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results
Time Frame: White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes
White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
The concordance rate between the results of endoscopic cerenkov luminescence imaging for the diagnosis of early colorectal malignancies and the histopathological results
Time Frame: Endoscopic cerenkov luminescence imaging time: 1-5 minutes
Endoscopic cerenkov luminescence imaging time: 1-5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Study Director: Wu kaichun, PhD, Xijing Hospital of Digestive Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 11, 2022

Primary Completion (Estimated)

April 10, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XijingMDERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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