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
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedDecember 30, 2014
December 1, 2014
3 years
February 5, 2014
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Other Outcomes (1)
Optical properties of cancerous and healthy ureter and collecting system tissue
up to 10 minutes
Study Arms (1)
optical coherence tomography
EXPERIMENTALA single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)
Interventions
Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy
Eligibility Criteria
You may qualify if:
- Candidate for diagnostic or therapeutic ureterorenoscopy
- Signed informed consent
You may not qualify if:
- No signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
Related 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: 10.1016/j.juro.2013.08.006. Epub 2013 Aug 13.
PMID: 23954585RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean J. de la Rosette, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 5, 2014
First Posted
December 30, 2014
Study Start
December 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12