Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues

Known or Suspected Dysplasia or Cancer Clinical Trial

Official title:

Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01968863
• Other study ID #: 202224
• Status: Terminated
• Phase: N/A
• First received: October 15, 2013
• Last updated: July 8, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The overall objective of this exploratory, laboratory study is to evaluate whether noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting dysplastic (precancerous) areas during standard surveillance. This is a study designed to evaluate the feasibility of using prototype imaging technology to enhance the detection of precancerous changes in various tissues. The results of this laboratory study will be used to further develop the technology for clinical application.

The primary aim of this project will be to investigate what digital image analysis criteria can be used to best detect dysplasia in various types of resected tissue.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females over the age of 18 scheduled for standard of care resection of abnormal tissue

Exclusion Criteria:

• Previous chemotherapy or radiation treatment to the tissue to be resected

• Inability to provide consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Known or Suspected Dysplasia or Cancer

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistical measurements of the spatial and intensity distributions of pixels within an image	The statistical measurements will be used to correlate each microendoscope image to a histopathology diagnosis.	Up to 24 hours	No