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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366586
First Posted: June 6, 2011
Last Update Posted: December 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanqing Li, Shandong University
  Purpose

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 .

Condition
Gastric Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7 Antigen

Resource links provided by NLM:


Further study details as provided by Yanqing Li, Shandong University:

Biospecimen Retention:   Samples With DNA
Taken biopsies during endoscopy

Enrollment: 5
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with endoscopically diagnosed gastric cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366586


Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital
  More Information

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01366586     History of Changes
Other Study ID Numbers: 2011SDU-QILU-G02
First Submitted: June 2, 2011
First Posted: June 6, 2011
Last Update Posted: December 30, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases