NCT05575765

Clinical Validation of Multimodal Digestive Endoscopy

Suspended Last updated 2 April 2025

What this trial tests

trial in Colorectal Neoplasms in 20 participants. Suspended.

Timeline

11 November 2022

Primary endpoint
10 April 2025

10 April 2025

Quick facts

Lead sponsor	Xijing Hospital of Digestive Diseases
Status	Suspended
Study type	OBSERVATIONAL
Enrollment	20
Start date	11 November 2022
Primary completion	10 April 2025
Estimated completion	10 April 2025
Sites	1 location across China

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Confocal Laser Endomicroscopy — all drugs for Confocal Laser Endomicroscopy →
• Endoscopy, Digestive System — all drugs for Endoscopy, Digestive System →
• Molecular Imaging — all drugs for Molecular Imaging →

Sponsor

Xijing Hospital of Digestive Diseases

Who can join

Adults 18 to 80, any sex, with Colorectal Neoplasms or Confocal Laser Endomicroscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current clinical applications of Cerenkov luminescence for intraoperative molecular imaging.
   Boykoff N, Grimm J. · · 2024 · cited 6× · PMID 38243119 · DOI 10.1007/s00259-024-06602-3
2. Early diagnosis of colorectal cancer using Cerenkov luminescence endoscopy: a pilot trial involving humans for the first time.
   Yang Z, Wu Z, Pang T, Liu D, et al · · 2026 · PMID 41608582 · DOI 10.7150/thno.122007