Multimodal Imaging Based on Pathological and Genomic Characteristics

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Mitochondrial DNA Mutation
• Intervention / Treatment: Other: Patients diagnosed as gastrointestinal mucosal lesions

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yan Liu, MD; Phone Number: +8613911798288; Email: 13911798288@163.com
• Study Contact Backup: Name: Liang Wu, MD; Phone Number: +8618110076598; Email: wuliangdoc@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • The First Medical Center of Chinese PLA General Hospital
      • Contact: Yan Liu; Phone Number: +8613911798288; Email: 13911798288@163.com
      • Principal Investigator: Yan Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People diagnosed or suspected of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, colorectal cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Study on the genomic and molecular pathological characteristics of gastrointestinal mucosal lesions	Other: Patients diagnosed as gastrointestinal mucosal lesions; Patients diagnosed as gastritis, gastric cancer, intestinal polyps and colorectal cancer
Control Group; Study on the genomic and molecular pathological characteristics of normal gastrointestinal mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: multimodal imaging; Molecular pathology; Single cell sequencing; Mitochondrial DNA Mutation; holography
• Other Study ID Numbers: Multi-imaging

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No