The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia

The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.

This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Confocal LASER Endomicroscopy

Detailed Description

Confocal Laser Endomicroscopy (CLE) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. CLE aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia.

This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).

Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.

• Study Type: Interventional
• Enrollment (Anticipated): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Urology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
• Suspicious mucosa / Carcinoma in situ
• Recurrent pTa
• Positive cytology with normal flexible cystoscopy
• Control after Bacille Calmette Guérin (BCG) treatment

Exclusion Criteria:

• Allergy to fluorescein
• Pregnant and lactating women.
• Renal failure (eGFR <20 ml / min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CLE; CLE assessed by the pathologist	Device: Confocal LASER Endomicroscopy; Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.; Other Names: Cellvisio
Active Comparator: Biopsy; Histology assessed by the pathologist	Device: Confocal LASER Endomicroscopy; Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.; Other Names: Cellvisio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accordance between CLE and histology in flat bladder tumors	Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia	An average of 18 months
Accordance between CLE and histology in exophytic bladder tumors	Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia	An average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accordance between CLE assessed by the surgeon and histology.	Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the surgeon in both flat and exophytic bladder neoplasia	An average of 18 months
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon	Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon	An average of 18 months

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Sami Beji, MD, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: H-15020548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No