Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01968863

Enrollment

Registered

2013-10-24

Start date

2013-11-30

Completion date

2015-07-31

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Known or Suspected Dysplasia or Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Statistical measurements of the spatial and intensity distributions of pixels within an image	Up to 24 hours	The statistical measurements will be used to correlate each microendoscope image to a histopathology diagnosis.

Countries

United States

Outcome results