Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography

Conditions
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Kidney/Urinary Cancer

Intervention / Treatment
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* Device: optical coherence tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: optical coherence tomography for diagnosis<br>Patients undergo optical coherence tomography over 10-15 minutes. | Device: optical coherence tomography<br>* Undergo optical coherence tomography<br>|

What is the study measuring?
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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 |