Use of Multiphoton Microscopy in the Diagnosis of Cancer | NCT00652210

Studies
Use of Multiphoton Microscopy in the Diagnosis of Cancer

NCT00652210

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Dec 10, 2015Estimated

Enrollment

344Actual

Phase

Phase 1

Conditions

Bladder Cancer
Prostate Cancer

Interventions

Multiphoton microscopy

Countries

United States

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

Status Module

Record Verification Date

Dec 2015

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

Jun 2005

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 3, 2008Estimated

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

Dec 8, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Douglas S. Scherr, Associate Professor, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MPM	Experimental	Subject tissue was reviewed using multiphoton microscopy	Other: Multiphoton microscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multiphoton microscopy	Other	Use of multiphoton microscopy to diagnose cancer	MPM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		10/14/2007 to 2/15/2008

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anyone who presents with bladder and/or prostate cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas S Scherr, M.D.	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms
D011471	Prostatic 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

Intervention Browse Module

MeSH Terms

ID	Term
D036641	Microscopy, Fluorescence, Multiphoton

Ancestor Terms

ID	Term
D008856	Microscopy, Fluorescence
D008853	Microscopy
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided