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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with a clinical diagnosis of colorectal cancer, colorectal polyps, and colorectal adenomas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital of Digestive Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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