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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Confocal LASER Endomicroscopy
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Urology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

CLE

Biopsy

Arm Description

CLE assessed by the pathologist

Histology assessed by the pathologist

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
July 7, 2016
Last Updated
March 5, 2018
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02841904
Brief Title
The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
Official Title
The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLE
Arm Type
Other
Arm Description
CLE assessed by the pathologist
Arm Title
Biopsy
Arm Type
Active Comparator
Arm Description
Histology assessed by the pathologist
Intervention Type
Device
Intervention Name(s)
Confocal LASER Endomicroscopy
Other Intervention Name(s)
Cellvisio
Intervention Description
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.
Primary Outcome Measure Information:
Title
accordance between CLE and histology in flat bladder tumors
Description
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia
Time Frame
An average of 18 months
Title
Accordance between CLE and histology in exophytic bladder tumors
Description
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia
Time Frame
An average of 18 months
Secondary Outcome Measure Information:
Title
Accordance between CLE assessed by the surgeon and histology.
Description
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the surgeon in both flat and exophytic bladder neoplasia
Time Frame
An average of 18 months
Title
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
Description
Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
Time Frame
An average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sami Beji, MD
Phone
53720546
Ext
+45
Email
sami.beji.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Ladefoged Kopp Schmidt
Phone
3868 1100
Ext
+45
Email
Mette.Ladefoged.Kopp.Schmidt@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sami Beji, MD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology department
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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