Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

American BioOptics, LLC600 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Colon Cancer

Interventions

LEBS - Low coherence enhanced backscatteringDEVICE

Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.