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Endoscopic Subsurface Optical Imaging for Cancer Detection

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ClinicalTrials.gov Identifier: NCT01810445
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease
Bladder Cancer

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

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endoscopic Subsurface Optical Imaging for Cancer Detection
Study Start Date : January 1999
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



Primary Outcome Measures :
  1. 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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients already scheduled to undergo a bladder surgery at UCDMC.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810445


Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Stavros Demos, PhD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01810445     History of Changes
Other Study ID Numbers: 200210092-9
Endoscopic Subsurface Study
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013
Keywords provided by University of California, Davis:
Bladder Cancer
Laser
Optical
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases