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

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Device: Confocal LASER Endomicroscopy

• Registration Number: NCT02841904
• Lead Sponsor: Herlev Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-22
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06
• Study Start: 2018-06
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 189

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLE	Confocal LASER Endomicroscopy	CLE assessed by the pathologist
Biopsy	Confocal LASER Endomicroscopy	Histology assessed by the pathologist

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology department; 🇩🇰 Herlev, Denmark