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CompletedNCT01372189Updated Feb 1, 2012

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

An observational study in Colorectal Cancer and Colorectal Adenoma, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-01.

Sponsored by Shandong University · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study 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 .
Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Colorectal Adenoma

Keywords

  • molecular imaging
  • epidermal growth factor receptor
  • colorectal neoplasia
  • confocal laser endomicroscopy
03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 40 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Time perspective
Prospective
Enrollment
40 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • colorectal cancer

    Patients with colorectal carcinoma during conventional endoscopic imaging.

  • colorectal adenoma

    Patients with colorectal adenoma during conventional endoscopic imaging.

06

Study locations

1 site
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong, China
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01372189
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University) — Principal investigator
First posted
Jun 13, 2011
Start date
Jan 2011
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Feb 1, 2012

Study contacts

Yanqing Li, PhD. MD.
study director · Department of Gastroenterology, Qilu Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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