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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
June 2, 2011
June 6, 2011
December 30, 2011
May 2011
July 2011   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT01366586 on ClinicalTrials.gov Archive Site
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Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7-Ag
Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7 Antigen

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 .
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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Taken biopsies during endoscopy
Non-Probability Sample
patients with endoscopically diagnosed gastric cancer
Gastric Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01366586
2011SDU-QILU-G02
Yes
Not Provided
Not Provided
Yanqing Li, Shandong University
Shandong University
Not Provided
Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital
Shandong University
December 2011