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Trial record 21 of 26 for:    upper tract urothelial

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

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ClinicalTrials.gov Identifier: NCT02326909
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
M.T.J. Bus, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Transitional Cell Carcinoma of Urinary Tract Device: Optical Coherence Tomography Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for diagnostic or therapeutic ureterorenoscopy
  • Signed informed consent

Exclusion Criteria:

  • No signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326909


Locations
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Netherlands
Academic Medical Center
Amsterdam, Noord Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jean J. de la Rosette, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications of Results:
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Responsible Party: M.T.J. Bus, M.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02326909     History of Changes
Other Study ID Numbers: NL42100.018.12
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by M.T.J. Bus, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Upper Urinary Tract
Optical Coherence Tomography
Transitional Cell Carcinoma
Urothelial Cell Carcinoma
Diagnostic accuracy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms