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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326909
• Other study ID #: NL42100.018.12
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: December 29, 2014
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate for diagnostic or therapeutic ureterorenoscopy

• Signed informed consent

Exclusion Criteria:

• No signed informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of Urinary Tract

Intervention

Device:
• Optical Coherence Tomography
Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy
• Optical Coherence Tomography
A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optical properties of cancerous and healthy ureter and collecting system tissue	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	No
Primary	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	No
Primary	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	No