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Trial Title:
Clinical Validation of Multimodal Digestive Endoscopy
NCT ID:
NCT05575765
Condition:
Colorectal Neoplasms
Confocal Laser Endomicroscopy
Molecular Imaging
Endoscopy, Digestive System
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Probe-based confocal laser endomicroscopy
Endoscopic cerenkov luminescence imaging
Multimodal digestive endoscopy
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
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, twenty patients with colorectal 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.
Criteria for eligibility:
Study pop:
grade III A hospital
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Age >18 years old.
2. Clinical diagnosis of colorectal cancer, colorectal polyps and colorectal adenomas.
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. Women who are pregnant or breastfeeding
3. Person without personal freedom and independent civil capacity.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital
Address:
City:
Xi'an
Zip:
710000
Country:
China
Start date:
August 14, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Xijing Hospital of Digestive Diseases
Agency class:
Other
Source:
Xijing Hospital of Digestive Diseases
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05575765
