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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372189
• Other study ID #: 2011SDU-QILU-G01
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: January 30, 2012
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Adenoma
• Colorectal Cancer

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China,