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Use of Multiphoton Microscopy in the Diagnosis of Cancer (MPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652210
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Douglas S. Scherr, Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE April 3, 2008
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
After several delays, the multiphoton microscope has been delivered to Weill Cornell Medical College. We have been using this time to set-up and fine tune the multiphoton microscope. As of current, no negative events have occurred. [ Time Frame: 10/14/2007 to 2/15/2008 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Multiphoton Microscopy in the Diagnosis of Cancer
Official Title  ICMJE Use of Multiphoton Microscopy in the Diagnosis of Cancer
Brief Summary Multiphoton microscopy (MPM) has been shown to be able to image tissue at a cellular level. Our project will initially evaluated the ability of MPM imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. After development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. After exhibiting usefulness of MPM imaging for bladder cancer, we will look at other organs beginning with the colon.
Detailed Description Same as above
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Bladder Cancer
  • Prostate Cancer
Intervention  ICMJE Other: Multiphoton microscopy
Use of multiphoton microscopy to diagnose cancer
Study Arms  ICMJE Experimental: MPM
Subject tissue was reviewed using multiphoton microscopy
Intervention: Other: Multiphoton microscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
344
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2008)
100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anyone who presents with bladder and/or prostate cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652210
Other Study ID Numbers  ICMJE 0506007919
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Douglas S. Scherr, Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas S Scherr, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP