Clinical Validation of Multimodal Digestive Endoscopy

Colorectal Neoplasms Clinical Trial

Official title:

Clinical Validation of Multimodal Digestive Endoscopy in Colorectal Cancer Diagnosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05575765
• Other study ID #: XijingMDERC
• Status: Enrolling by invitation
• Start date: August 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor images of multimodal digestive endoscopy, combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE)	Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's rectal cancer in order to acquire tumor images.	White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes