Endoscopic Subsurface Optical Imaging for Cancer Detection | NCT01810445

Studies
Endoscopic Subsurface Optical Imaging for Cancer Detection

NCT01810445

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Mar 13, 2013Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Endoscopic Subsurface Study

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 2, 2011

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2013

Last Update Posted Date

Mar 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
1		Patients undergoing a surgical bladder procedure in the main O.R.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients already scheduled to undergo a bladder surgery at UCDMC.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stavros Demos, PhD	University of California, Davis	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided