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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02841904
• Other study ID #: H-15020548
• Status: Not yet recruiting
• Phase: N/A
• First received: July 7, 2016
• Last updated: March 5, 2018
• Start date: June 2018
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Herlev Hospital
• Contact: Sami Beji, MD
• Phone: 53720546
• Email: sami.beji.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 189
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Urology department	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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