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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841904
Recruitment Status : Unknown
Verified March 2018 by Sami Beji, MD, Herlev Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sami Beji, MD, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: Confocal LASER Endomicroscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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 Name: 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 Name: Cellvisio




Primary Outcome Measures :
  1. accordance between CLE and histology in flat bladder tumors [ Time Frame: An average of 18 months ]
    Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia

  2. Accordance between CLE and histology in exophytic bladder tumors [ Time Frame: 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 :
  1. Accordance between CLE assessed by the surgeon and histology. [ Time Frame: 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

  2. Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon [ Time Frame: An average of 18 months ]
    Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841904


Contacts
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Contact: Sami Beji, MD 53720546 ext +45 sami.beji.01@regionh.dk
Contact: Mette Ladefoged Kopp Schmidt 3868 1100 ext +45 Mette.Ladefoged.Kopp.Schmidt@regionh.dk

Locations
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Denmark
Urology department
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Sami Beji, MD Herlev Hospital
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Responsible Party: Sami Beji, MD, Medical doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02841904    
Other Study ID Numbers: H-15020548
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases