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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yanqing Li, Shandong University

ClinicalTrials.gov Identifier:

NCT01372189

First received: January 18, 2011

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2011

Last Updated Date

January 30, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

fluorescence intensity of colorectal neoplastic lesions by molecular imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01372189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

positive rates of EGFR expression in lesions with different histological grades by molecular imaging [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The study aims to:

Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using confocal laser endomicroscopy.
Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo immunohistochemistry .

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 ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Take biospecimen during colonoscopy.

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

Condition ^ICMJE

Colorectal Cancer
Colorectal Adenoma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

colorectal cancer
Patients with colorectal carcinoma during conventional endoscopic imaging.
colorectal adenoma
Patients with colorectal adenoma during conventional endoscopic imaging.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01372189

Other Study ID Numbers ^ICMJE

2011SDU-QILU-G01

Has Data Monitoring Committee

Yes

Responsible Party

Yanqing Li, Shandong University

Study Sponsor ^ICMJE

Shandong University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Yanqing Li, PhD. MD.

Department of Gastroenterology, Qilu Hospital

Information Provided By

Shandong University

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top