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NCT02730702 Clinical Trial

Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Colon Cancer Clinical Trial

Official title:
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02730702
Other study ID # ABO 2016-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date September 2020

Study information
Verified date July 2018
Source American BioOptics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

Description:

The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance

Exclusion Criteria:

- age <50

- personal/family history of colonic neoplasia

- personal history of coagulopathy

- (retrospectively) failure to complete or inadequate colonoscopy

- any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LEBS - Low coherence enhanced backscattering
Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.

Locations
Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
American BioOptics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Radosevich AJ, Mutyal NN, Eshein A, Nguyen TQ, Gould B, Rogers JD, Goldberg MJ, Bianchi LK, Yen EF, Konda V, Rex DK, Van Dam J, Backman V, Roy HK. Rectal Optical Markers for In Vivo Risk Stratification of Premalignant Colorectal Lesions. Clin Cancer Res. 2015 Oct 1;21(19):4347-4355. doi: 10.1158/1078-0432.CCR-15-0136. Epub 2015 May 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon. Through study completion, an average of 1 year
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