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

NCT ID: NCT02326909

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

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.

Conditions

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Transitional Cell Carcinoma of Urinary Tract

Keywords

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Upper Urinary Tract Optical Coherence Tomography Transitional Cell Carcinoma Urothelial Cell Carcinoma Diagnostic accuracy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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optical coherence tomography

A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)

Group Type EXPERIMENTAL

Optical Coherence Tomography

Intervention Type DEVICE

Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy

Optical Coherence Tomography

Intervention Type DEVICE

A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)

Interventions

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Optical Coherence Tomography

Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy

Intervention Type DEVICE

Optical Coherence Tomography

A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)

Intervention Type DEVICE

Other Intervention Names

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1300 nm Optical Coherence Tomography

Eligibility Criteria

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Inclusion Criteria

* Candidate for diagnostic or therapeutic ureterorenoscopy
* Signed informed consent

Exclusion Criteria

* No signed informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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M.T.J. Bus

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean J. de la Rosette, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Bus MT, Muller BG, de Bruin DM, Faber DJ, Kamphuis GM, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Volumetric in vivo visualization of upper urinary tract tumors using optical coherence tomography: a pilot study. J Urol. 2013 Dec;190(6):2236-42. doi: 10.1016/j.juro.2013.08.006. Epub 2013 Aug 13.

Reference Type RESULT
PMID: 23954585 (View on PubMed)

Other Identifiers

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NL42100.018.12

Identifier Type: -

Identifier Source: org_study_id