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Trial record 11 of 26 for:    upper tract urothelial

Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

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. Identifier: NCT02108587
Recruitment Status : Withdrawn (Funding unavailable)
First Posted : April 9, 2014
Last Update Posted : October 20, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients with upper-tract urothelial carcinomas.

Condition or disease Intervention/treatment Phase
Kidney/Urinary Cancer Device: optical coherence tomography Not Applicable

Detailed Description:


I. To test the feasibility and imaging ability of optical coherence tomography (OCT) to stage upper-tract urothelial carcinomas (UTUC).


Patients undergo optical coherence tomography over 10-15 minutes.

After completion of study, patients are followed up at 3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography
Study Start Date : December 2016
Estimated Primary Completion Date : March 2017

Arm Intervention/treatment
Experimental: optical coherence tomography for diagnosis
Patients undergo optical coherence tomography over 10-15 minutes.
Device: optical coherence tomography
Undergo optical coherence tomography

Primary Outcome Measures :
  1. Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC) [ Time Frame: Up to 3 months ]
    Feasibility defined as the ability to relate the features associated with cancerous tissues in pathohistological analysis to the features in OCT images

Secondary Outcome Measures :
  1. Imaging Analysis [ Time Frame: Up to 3 months ]
    Number of cancerous images with at least one feature different from normal pathology slide

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have radiographic evidence of upper tract urothelial cancer by computed tomography (CT), magnetic resonance imaging (MRI) or intravenous pyelogram (IVP) in order to undergo this procedure
  • Patient who will undergo standard of care clinical staging for UTUC
  • Patient ability to read and comprehend the informed consent document

Exclusion Criteria:

  • Patient who has a contraindication to endoscopy
  • Patient who is pregnant

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 identifier (NCT number): NCT02108587

Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Donald Bodner, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center Identifier: NCT02108587     History of Changes
Other Study ID Numbers: CASE11811
NCI-2014-00347 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 11811 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016