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

Shandong University

Status: Completed

Conditions: Colorectal Adenoma; Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01372189

2011SDU-QILU-G01

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 2 patient groups

colorectal cancer

Description:

Patients with colorectal carcinoma during conventional endoscopic imaging.

colorectal adenoma

Description:

Patients with colorectal adenoma during conventional endoscopic imaging.