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

Primary Purpose

Transitional Cell Carcinoma of Urinary Tract

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Optical Coherence Tomography

About this trial

This is an interventional diagnostic trial for Transitional Cell Carcinoma of Urinary Tract focused on measuring Upper Urinary Tract, Optical Coherence Tomography, Transitional Cell Carcinoma, Urothelial Cell Carcinoma, Diagnostic accuracy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Candidate for diagnostic or therapeutic ureterorenoscopy
Signed informed consent

Exclusion Criteria:

No signed informed consent

Sites / Locations

Academic Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

optical coherence tomography

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02326909

First Posted

February 5, 2014

Last Updated

December 29, 2014

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02326909

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transitional Cell Carcinoma of Urinary Tract

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

optical coherence tomography

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography

Other Intervention Name(s)

1300 nm Optical Coherence Tomography

Intervention Description

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

Primary Outcome Measure Information:

Title

Sensitivity of 1300nm OCT in grading and staging UUT-UC

Description

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

Time Frame

up to 10 minutes

Title

Specificity of 1300nm OCT in grading and staging UUT-UC

Description

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

Time Frame

up to 10 minutes

Other Pre-specified Outcome Measures:

Title

Optical properties of cancerous and healthy ureter and collecting system tissue

Description

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

Time Frame

up to 10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean J. de la Rosette, MD PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Academic Medical Center

City

Amsterdam

State/Province

Noord Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

23954585

Citation

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.

Results Reference

result

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

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