Multimodal Imaging Based on Pathological and Genomic Characteristics

Endoscopy Clinical Trial

Official title:

A New Multimodal Imaging Technique Based on Pathological and Genomic Characteristics of Gastrointestinal Mucosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196243
• Other study ID #: Multi-imaging
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2022
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Yan Liu, MD
• Phone: +8613911798288
• Email: 13911798288[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mitochondrial DNA mutations in normal gastric tissue, early gastric cancer and advanced gastric cancer were identified by single cell sequencing, and the origin of gastric stem cells was traced and new molecular markers were found. At the same time, organize industry-university-research-medical inspection joint research, aiming at the advanced layout of new structural and functional imaging technologies, combined with some new imaging technologies, such as holography, fluorescence, etc., to explore and develop a new composite endoscopic imaging technology that is advanced, original and suitable for China's national conditions, in order to develop a prototype of multimodal structural and functional imaging digestive endoscope without contrast agent.

Description:

In this study, on the basis of previous work, aiming at the visualization of key molecular functions of gastric cancer, a full-chain digestive endoscopic diagnosis system was constructed by using cross-scale medical imaging technology. Mitochondrial DNA mutations in normal gastric tissue, early gastric cancer and advanced gastric cancer were identified by single cell sequencing, and the origin of gastric stem cells was traced and new molecular markers were found. The tissue characteristics are analyzed by the full spectrum imaging device, and the location, distribution and aggregation of key molecules on the cell membrane are observed by the high resolution imaging device, so as to develop an imaging probe with high labeling efficiency and biosafety, and to explore its clinical application to realize the information fusion of structural and functional imaging in the evolution and diagnosis and treatment of gastrointestinal tumors. The structural heterogeneity and molecular heterogeneity of gastrointestinal tumors are clarified from the macro-micro levels, and the full-scale imaging system with the most comprehensive visualization and resolution ability is established from multi-information dimensions and multi-imaging scales.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Diagnosis or suspected diagnosis of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, bowel cancer

2. Written informed consent

Exclusion Criteria:

1. Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system

2. Mental patients

3. Hemorrhagic diseases

4. Platelet count < 50 × 10 ^ 9 / L

5. Allergic constitution

6. unable to tolerate or cooperate with endoscopy

7. Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.

8. Pregnant or lactating women

Related Conditions & MeSH terms

• Endoscopy

Intervention

Other:
• Patients diagnosed as gastrointestinal mucosal lesions
Patients diagnosed as gastritis, gastric cancer, intestinal polyps and colorectal cancer

Locations

Country	Name	City	State
China	The First Medical Center of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single cell sequencing and identification of mitochondrial DNA variation in gastrointestinal lesions	Single cell sequencing and identification of mitochondrial DNA mutations in gastrointestinal lesions were carried out to trace the clonal origin of cells and look for molecular markers	1 month
Primary	To explore the multimodal imaging technique for the diagnosis of gastrointestinal mucosal lesions	The tissue characteristics are analyzed by the full spectrum imaging device, the location, distribution and aggregation of key molecules on the cell membrane are observed by the high resolution imaging device, the imaging probe with high labeling efficiency and biosafety is developed, and the clinical application is discussed. in order to realize the information fusion of structural and functional imaging in the process of gastrointestinal tumor evolution and diagnosis and treatment.	1 month