Clinical Validation of Multimodal Digestive Endoscopy

NCT ID: NCT05575765

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-11

Study Completion Date

2025-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms Confocal Laser Endomicroscopy Endoscopy, Digestive System Molecular Imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Kaichun Wu

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wu kaichun, PhD

Role: STUDY_DIRECTOR

Xijing Hospital of Digestive Diseases

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Chen X, Wang X, Yan T, Zheng Y, Cao H, Ren F, Cao X, Meng X, Lu X, Liang S, Wu K. Sensitivity improved Cerenkov luminescence endoscopy using optimal system parameters. Quant Imaging Med Surg. 2022 Jan;12(1):425-438. doi: 10.21037/qims-21-373.

Reference Type BACKGROUND
PMID: 34993091 (View on PubMed)

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

Schillaci O, Scimeca M, Toschi N, Bonfiglio R, Urbano N, Bonanno E. Combining Diagnostic Imaging and Pathology for Improving Diagnosis and Prognosis of Cancer. Contrast Media Mol Imaging. 2019 Jul 1;2019:9429761. doi: 10.1155/2019/9429761. eCollection 2019.

Reference Type BACKGROUND
PMID: 31354394 (View on PubMed)

Moghbeli M. MicroRNAs as the critical regulators of Cisplatin resistance in ovarian cancer cells. J Ovarian Res. 2021 Sep 30;14(1):127. doi: 10.1186/s13048-021-00882-1.

Reference Type BACKGROUND
PMID: 34593006 (View on PubMed)

Fan X, Qin X, Zhang Y, Li Z, Zhou T, Zhang J, You W, Li W, Pan K. Screening for gastric cancer in China: Advances, challenges and visions. Chin J Cancer Res. 2021 Apr 30;33(2):168-180. doi: 10.21147/j.issn.1000-9604.2021.02.05.

Reference Type BACKGROUND
PMID: 34158737 (View on PubMed)

Luu XQ, Lee K, Jun JK, Suh M, Jung KW, Choi KS. Effect of gastric cancer screening on long-term survival of gastric cancer patients: results of Korean national cancer screening program. J Gastroenterol. 2022 Jul;57(7):464-475. doi: 10.1007/s00535-022-01878-4. Epub 2022 May 14.

Reference Type BACKGROUND
PMID: 35568752 (View on PubMed)

Hamashima C, Goto R. Potential capacity of endoscopic screening for gastric cancer in Japan. Cancer Sci. 2017 Jan;108(1):101-107. doi: 10.1111/cas.13100. Epub 2016 Dec 12.

Reference Type BACKGROUND
PMID: 27727490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25360380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25577521 (View on PubMed)

Other Identifiers

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XijingMDERC

Identifier Type: -

Identifier Source: org_study_id

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