Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney/Urinary Cancer
• Intervention / Treatment: Device: optical coherence tomography

Detailed Description

PRIMARY OBJECTIVES:

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

OUTLINE:

Patients undergo optical coherence tomography over 10-15 minutes.

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging Analysis	Number of cancerous images with at least one feature different from normal pathology slide	Up to 3 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Donald Bodner, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CASE11811; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00347 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 11811 (Other Identifier: Case Comprehensive Cancer Center)