Transitional Cell Carcinoma of Urinary Tract Clinical Trial
Official title:
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
The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic