Urothelial Carcinoma Clinical Trial
Official title:
Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis
NCT number | NCT03013894 |
Other study ID # | 2015_300 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 2017 |
Verified date | June 2018 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 73 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients >18 years old - Bladder tumor(s) - Candidate for TURB - Signed informed consent Exclusion Criteria: - Patients <18 years old - Patients with known allergy for fluorescein - Possible pregnancy or lactating women - No signed informed consent |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract | Qualitatively correlating CLE images to histopathology to define CLE characteristics | 1.5 years |
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