Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies

NCT00874263 | Completed DMC

• 2 other identifiers: 07-007521ASGE Grant#FNDT-1
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new Confocal probe system can find pre-cancerous abnormalities in the stomach and colon. Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard colonoscopies could help the classification in vivo of colorectal neoplastic and non-neoplastic lesions. This could direct further endoscopic interventions such as targeted biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions during screening colonoscopies. Primary Aim

1. 1.To determine the key confocal image features of neoplastic and pre-neoplastic colorectal lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and cancer as well as benign lesions such as hyperplastic polyps and normal colonic epithelium and to estimate which morphologic features best distinguish neoplastic and non-neoplastic tissues.
2. 2.To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon.
3. 3.In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as:
4. 4.Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus.
5. 5.Other encountered inflammatory and neoplastic conditions within the GI tract in which biopsy or removal of tissue would routinely be indicated.

Conditions

Colonic Polyps; Esophageal Diseases

Keywords

Probe-based imaging of GI pre-malignant or malignant lesions

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (1)

• Endoscopic Confocal microscopy has the potential to fundamentally change the way endoscopy and pathology interact by allowing near histological-quality imaging in vivo, without the need, risk, and cost of tissue removal.

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to Mayo Clinic, Jacksonville, Florida for a screening, surveillance colonoscopy, and/or a diagnostic and surveillance upper endoscopy, will be eligible based on inclusion and exclusion criteria. Eligible patients will be offered entry into the study on the day of the procedure in the hospital GI or Mayo Clinic Jacksonville endoscopy suites.

You may qualify if:

• Ages 18 to 100
• Any patient undergoing screening and/or surveillance colonoscopy and/or upper endoscopy with possible biopsy or removal of tissue by polypectomy

You may not qualify if:

• Unwilling to consent
• Allergy to fluorescein
• 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)
• Women of child-bearing age who are sexually active and not practicing an acceptable form of contraception

Sponsors & Collaborators

• Mayo Clinic: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (3)

• Andre B, Vercauteren T, Buchner AM, Krishna M, Ayache N, Wallace MB. Software for automated classification of probe-based confocal laser endomicroscopy videos of colorectal polyps. World J Gastroenterol. 2012 Oct 21;18(39):5560-9. doi: 10.3748/wjg.v18.i39.5560.

  PMID: 23112548 DERIVED

• Shahid MW, Buchner A, Gomez V, Krishna M, Woodward TA, Raimondo M, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy and narrow band imaging in detection of dysplasia in duodenal polyps. J Clin Gastroenterol. 2012 May-Jun;46(5):382-9. doi: 10.1097/MCG.0b013e318247f375.

  PMID: 22499072 DERIVED

• Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.

  PMID: 19909747 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Esophageal Diseases

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael B Wallace, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)