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Clinical Validation of Multimodal Digestive Endoscopy

Sponsor
Xijing Hospital of Digestive Diseases (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05575765
Collaborator
(none)
6
Enrollment
1
Location
7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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, six patients with rectal cancer 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 rectal cancer. ECLI images were compared with PET-CT images, and pCLE images were compared with tumor histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Validation of Multimodal Digestive Endoscopy in Rectal Cancer Diagnosis
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with advanced rectal cancer

    Outcome Measures

    Primary Outcome Measures

    1. Tumor images of multimodal digestive endoscopy, combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) [White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes]

      Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's rectal cancer in order to acquire tumor images.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age >18 years old.

    2. Clinical diagnosis of rectal cancer of at least cT2N0M0 or higher stage by endoscopy and biopsy.

    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 rectal cancer (endoscopic treatment, surgery , targeted therapy, and radiotherapy, etc.)

    2. Women who are pregnant or breastfeeding

    3. Person without personal freedom and independent civil capacity.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital Xi'an Shaanxi China 710000

    Sponsors and Collaborators

    • Xijing Hospital of Digestive Diseases

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kaichun Wu, vice president, Xijing Hospital of Digestive Diseases
    ClinicalTrials.gov Identifier:
    NCT05575765
    Other Study ID Numbers:
    • XijingMDERC
    First Posted:
    Oct 12, 2022
    Last Update Posted:
    Oct 12, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaichun Wu, vice president, Xijing Hospital of Digestive Diseases
    Probe-based confocal laser endomicroscopy
    Endoscopic cerenkov luminescence imaging
    Multimodal digestive endoscopy
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Oct 12, 2022