- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326909
Diagnostic Accuracy of Optical Coherence Tomography in Upper Urinary Tract Urothelial Carcinoma
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Noord Holland
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Amsterdam, Noord Holland, Netherlands, 1105 AZ
- Academic Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Candidate for diagnostic or therapeutic ureterorenoscopy
- Signed informed consent
Exclusion Criteria:
- No signed informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: optical coherence tomography
A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)
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Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy
A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of 1300nm OCT in grading and staging UUT-UC
Time Frame: up to 10 minutes
|
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
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up to 10 minutes
|
Specificity of 1300nm OCT in grading and staging UUT-UC
Time Frame: up to 10 minutes
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical properties of cancerous and healthy ureter and collecting system tissue
Time Frame: up to 10 minutes
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean J. de la Rosette, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL42100.018.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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