Diagnostic Accuracy of Optical Coherence Tomography in Upper Urinary Tract Urothelial Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.

Detailed Description
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Minimal invasive endoscopic treatment for Upper Urinary Tract Urothelial Carcinoma (UUT-UC) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. For this reason, information on tumour stage and grade is important for a clinical decision. Until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. Unfortunately, histology/cytology is often inconclusive. Optical Coherence Tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease. In this study the investigators aim to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma. Secondary objectives are inter-observer variability of 1300 nm OCT in the diagnosis of UUT-UC and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.

Official Title
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a Prospective In-vivo Human Study to Assess the Diagnostic Accuracy of Optical Coherence Tomography for Diagnosis and Staging of Upper Urinary Tract Urothelial Carcinoma

Conditions
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Transitional Cell Carcinoma of Urinary Tract

Intervention / Treatment
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* Device: Optical Coherence Tomography
* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for diagnostic or therapeutic ureterorenoscopy Signed informed consent Exclusion Criteria: No signed informed consent

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<br>A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s) | Device: Optical Coherence Tomography<br>* Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy<br>Device: Optical Coherence Tomography<br>* A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)<br>* Other names: 1300 nm Optical Coherence Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 1300nm OCT in grading and staging UUT-UC | Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device | up to 10 minutes | 
| Specificity of 1300nm OCT in grading and staging UUT-UC | Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device | up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Urinary Tract, Optical Coherence Tomography, Transitional Cell Carcinoma, Urothelial Cell Carcinoma, Diagnostic accuracy