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Confocal Laser Endomicroscopy in the Lower Urinary Tract

NCT03013894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2018-06-06

No results posted yet for this study

Summary

Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined.

Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.

Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology.

Secondary objectives:

* Assessing procedure related adverse events of CLE
* Assessing technical feasibility of CLE
* To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)

Conditions

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Jean J de la Rosette, prof. dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013894 on ClinicalTrials.gov