Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

Not Applicable

Withdrawn

• Conditions: Kidney/Urinary Cancer
• Interventions: Device: optical coherence tomography

• Registration Number: NCT02108587
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20
• Study Start: 2016-12
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
optical coherence tomography for diagnosis	optical coherence tomography	Patients undergo optical coherence tomography over 10-15 minutes.

Primary Outcome Measures

Name	Time	Method
Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC)	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

Name	Time	Method
Imaging Analysis	Up to 3 months	Number of cancerous images with at least one feature different from normal pathology slide