Clinical trial NCT05575765: Clinical Validation of Multimodal Digestive Endoscopy
Official title: Clinical Validation of Multimodal Digestive Endoscopy in the Diagnosis of Colorectal Lesions
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Colorectal Neoplasms
Confocal Laser Endomicroscopy
Endoscopy, Digestive System
Molecular Imaging
Keywords: Probe-based confocal laser endomicroscopy
Endoscopic cerenkov luminescence imaging
Multimodal digestive endoscopy
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: grade III A hospital

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results
timeFrame: White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes
Secondary outcomes:
measure: The concordance rate between the results of endoscopic cerenkov luminescence imaging for the diagnosis of early colorectal malignancies and the histopathological results
timeFrame: Endoscopic cerenkov luminescence imaging time: 1-5 minutes
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Wu kaichun, PhD
role: STUDY_DIRECTOR
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