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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

January 18, 2011
January 30, 2012
January 2011
July 2011   (final data collection date for primary outcome measure)
Not Provided
fluorescence intensity of colorectal neoplastic lesions by molecular imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01372189 on ClinicalTrials.gov Archive Site
Not Provided
positive rates of EGFR expression in lesions with different histological grades by molecular imaging [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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 .

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Take biospecimen during colonoscopy.

Non-Probability Sample

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

  • Colorectal Cancer
  • Colorectal Adenoma
Not Provided
  • colorectal cancer
    Patients with colorectal carcinoma during conventional endoscopic imaging.
  • colorectal adenoma
    Patients with colorectal adenoma during conventional endoscopic imaging.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01372189
2011SDU-QILU-G01
Yes
Yanqing Li, Shandong University
Shandong University
Not Provided
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital
Shandong University
January 2012

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