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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Completed
CT.gov ID
NCT02326909
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
36
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical Coherence Tomography
  • Device: Optical Coherence Tomography
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
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 :
Dec 1, 2011
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • 1300 nm Optical Coherence Tomography

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Candidate for diagnostic or therapeutic ureterorenoscopy

    • Signed informed consent

    Exclusion Criteria:
    • No signed informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Medical Center Amsterdam Noord Holland Netherlands 1105 AZ

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jean J. de la Rosette, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.T.J. Bus, M.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT02326909
    Other Study ID Numbers:
    • NL42100.018.12
    First Posted:
    Dec 30, 2014
    Last Update Posted:
    Dec 30, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by M.T.J. Bus, M.D., 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:
    Carcinoma
    Carcinoma, Transitional Cell

    Study Results

    No Results Posted as of Dec 30, 2014