Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7-Ag

NCT ID: NCT01366586

Last Updated: 2011-12-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to:

1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using confocal laser endomicroscopy.
2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo immunohistochemistry .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gastric cancer remains the world's second leading cause of cancer-related death. Improved prognosis essentially depend on earlier diagnosis. Gastric monoclonal antibody MG7 has been validated as a specific antibody in gastric cancerous tissue. Conventional evaluation of MG7 antigen expression is immunohistochemistry, which is time-consuming, and the immunoreactivity can be affected by storage and fixation of tissue. Confocal laser endomicrosopy enables visualization of the cellular and subcellular structures in vivo. Thus this study aims to achieve molecular imaging of MG7 antigen in gastric cancer in vivo using confocal laser endomicroscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with endoscopically diagnosed gastric cancer

Exclusion Criteria

* Patients who are allergic to fluorescein sodium
* Patients who are unwilling to sign or give the informed consent form
* Patients with giant tumors or obvious GI tract bleeding which make it hard or impossible to observe the lesions
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yanqing Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011SDU-QILU-G02

Identifier Type: -

Identifier Source: org_study_id