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

In Vivo Molecular Imaging of Epidermal Growth Factor Receptor in Patients With Colorectal Neoplasia Using Confocal Laser Endomicroscopy

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 .

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Adenoma

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
colorectal cancer; Patients with colorectal carcinoma during conventional endoscopic imaging.
colorectal adenoma; Patients with colorectal adenoma during conventional endoscopic imaging.

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Director: Yanqing Li, PhD. MD., Department of Gastroenterology, Qilu Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 1, 2012
• Last Update Submitted That Met QC Criteria: January 30, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: confocal laser endomicroscopy; colorectal neoplasia; molecular imaging; epidermal growth factor receptor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Adenoma
• Other Study ID Numbers: 2011SDU-QILU-G01