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Molecular Imaging of Epidermal Growth Factor Receptor in Colorectal Neoplasia Using Confocal Laser Endomicroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372189
First Posted: June 13, 2011
Last Update Posted: February 1, 2012
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 EGFR in patients with colorectal neoplasia in vivo using confocal laser endomicroscopy.
  2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo immunohistochemistry .

Condition
Colorectal Cancer Colorectal Adenoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: In Vivo Molecular Imaging of Epidermal Growth Factor Receptor in Patients With Colorectal Neoplasia Using Confocal Laser Endomicroscopy

Resource links provided by NLM:


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

Biospecimen Retention:   Samples With DNA
Take biospecimen during colonoscopy.

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
colorectal cancer
Patients with colorectal carcinoma during conventional endoscopic imaging.
colorectal adenoma
Patients with colorectal adenoma during conventional endoscopic imaging.

Detailed Description:
Various kinds of tumor markers have been shown to be over-expressed in colorectal cancer, including epidermal growth factor receptor(EGFR). The conventional detection method of EGFR expression in colorectal neoplasia is immunohistochemistry which is time-consuming, and the immunoreactivity can be affected by storage and fixation of tissues. Confocal laser endomicrosopy is a newly developed device which could identify the cellular and subcellular structures clearly with the magnification at×1000, making it possible to explore the physiological and pathological molecular mechanism of the gastrointestinal tract. So the study aims to achieve molecular imaging of EGFR in colorectal neoplasia 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 known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study
Criteria

Inclusion Criteria:

●Patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study

Exclusion Criteria:

  • Patients who are allergic to fluorescein sodium
  • Patients with impaired cardiac, liver or renal function
  • 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 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): NCT01372189


Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, PhD. MD. 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: NCT01372189     History of Changes
Other Study ID Numbers: 2011SDU-QILU-G01
First Submitted: January 18, 2011
First Posted: June 13, 2011
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Yanqing Li, Shandong University:
molecular imaging
epidermal growth factor receptor
colorectal neoplasia
confocal laser endomicroscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action