Endoscopic Subsurface Optical Imaging for Cancer Detection

March 11, 2013 updated by: University of California, Davis

The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.

Study Overview

Status

Completed

Conditions

Bladder Cancer

Detailed Description

This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients already scheduled to undergo a bladder surgery at UCDMC.

Description

Inclusion Criteria:

Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center.

Exclusion Criteria:

Non bladder surgical procedures at University of California Davis Medical Center.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Patients undergoing a surgical bladder procedure in the main O.R.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure. Time Frame: 1 year	Does the subsurface laser allow enough light to visually assess the cells. Logical metric of either "Yes" or "No".	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

Principal Investigator: Stavros Demos, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)