Clinical Validation of Multimodal Digestive Endoscopy

NCT05575765 | Suspended

• 1 other identifier: XijingMDERC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Colorectal Neoplasms; Confocal Laser Endomicroscopy; Endoscopy, Digestive System; Molecular Imaging

Keywords

Probe-based confocal laser endomicroscopy; Endoscopic cerenkov luminescence imaging; Multimodal digestive endoscopy

Outcome Measures

Primary Outcomes (1)

• The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results

  White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes

Secondary Outcomes (1)

• The concordance rate between the results of endoscopic cerenkov luminescence imaging for the diagnosis of early colorectal malignancies and the histopathological results

  Endoscopic cerenkov luminescence imaging time: 1-5 minutes

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

grade III A hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (10)

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• Cao X, Chen X, Kang F, Lin Y, Liu M, Hu H, Nie Y, Wu K, Wang J, Liang J, Tian J. Performance evaluation of endoscopic Cerenkov luminescence imaging system: in vitro and pseudotumor studies. Biomed Opt Express. 2014 Sep 17;5(10):3660-70. doi: 10.1364/BOE.5.003660. eCollection 2014 Oct 1.

  PMID: 25360380 BACKGROUND

• Hu H, Cao X, Kang F, Wang M, Lin Y, Liu M, Li S, Yao L, Liang J, Liang J, Nie Y, Chen X, Wang J, Wu K. Feasibility study of novel endoscopic Cerenkov luminescence imaging system in detecting and quantifying gastrointestinal disease: first human results. Eur Radiol. 2015 Jun;25(6):1814-22. doi: 10.1007/s00330-014-3574-2. Epub 2015 Jan 11.

  PMID: 25577521 BACKGROUND

• Yang Z, Wu Z, Pang T, Liu D, Wang X, Yu J, Xu S, Kang X, Liao D, Tian Z, Bai Y, Xi X, Yan T, Lu X, Qi Y, Zhang M, Zhao L, Kang F, Liang S, Wang J, Chen X, Wu K. Early diagnosis of colorectal cancer using Cerenkov luminescence endoscopy: a pilot trial involving humans for the first time. Theranostics. 2026 Jan 8;16(7):3685-3696. doi: 10.7150/thno.122007. eCollection 2026.

  PMID: 41608582 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wu kaichun, PhD

  Xijing Hospital of Digestive Diseases

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 12, 2022
• Study Start: November 11, 2022
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)