Know Cancer

forgot password

The Role of Endoscopic Confocal Microscopy in Diagnosing Colorectal Cancer and Other Gastrointestinal Pathologies in Vivo

18 Years
Not Enrolling
Colonic Polyps, Esophageal Diseases

Thank you

Trial Information

The Role of Endoscopic Confocal Microscopy in Diagnosing Colorectal Cancer and Other Gastrointestinal Pathologies in Vivo

Colorectal cancer is the second most common cause of cancer-related death in the U.S.
Although removal of pre-malignant polyps has been shown to reduce the risk of colorectal
cancer, up to 50% of removed colonic polyps are hyperplastic with no malignant potential.
Removal of these benign polyps exposes the patient to polypectomy-related complications and
cost without any benefit. Current standard endoscopes with the use of accessory confocal
endomicroscopy probe will allow both routine and confocal microscopy imaging. Colonoscopies
or upper endoscopies will be performed as routine including conscious sedation. A special
fiber through the scope, combined with a small amount of dye called fluorescein given by
vein, will be used to obtain microscopic views during the endoscopic procedure. If a
colorectal lesion or other GI lesion is found that would normally require biopsy, the site
of biopsy will be evaluated by confocal imaging with the Cellvizio-GI Fiberoptic probes
prior to biopsy or removal of the suspicious tissue. Following image acquisition, the lesion
will be biopsied or removed as per standard clinical care. Standard endoscopic variables for
each lesion will be recorded including: name and record number, date, time, an exact time of
fluorescein injection and time of image acquisition, lesion location, size, and suspected
findings (inflammation, dysplasia, type of polyp) and final histological diagnosis.

Inclusion Criteria:

1. Ages 18 to 100

2. Any patient undergoing screening and/or surveillance colonoscopy and/or upper
endoscopy with possible biopsy or removal of tissue by polypectomy

Exclusion Criteria:

1. Unwilling to consent

2. Allergy to fluorescein

3. Lack of any pathological state that would require biopsy at the time of endoscopy
(will be considered "screen failure" since this will not be known until after consent
is obtained and sedated endoscopy performed)

4. Women of child-bearing age who are sexually active and not practicing an acceptable
form of contraception

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Endoscopic Confocal microscopy may help distinguish small adenomatous polyps with malignant potential from non-neoplastic (hyperplastic) polyps in real- time enabling immediate diagnosis and removal of only polyps with truly malignant potential.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Michael B Wallace, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic Florida


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

June 2012

Related Keywords:

  • Colonic Polyps
  • Esophageal Diseases
  • Probe-based imaging of GI pre-malignant or malignant lesions
  • Colonic Polyps
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Gastrointestinal Neoplasms



Mayo Clinic Jacksonville, Florida  32224