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

NCT ID: NCT01372189

Last Updated: 2012-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Colorectal Cancer Colorectal Adenoma

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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colorectal cancer

Patients with colorectal carcinoma during conventional endoscopic imaging.

No interventions assigned to this group

colorectal adenoma

Patients with colorectal adenoma during conventional endoscopic imaging.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2011SDU-QILU-G01

Identifier Type: -

Identifier Source: org_study_id

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