Confocal Microscopy Dual Band in the Management of Bladder Cancer

Completed

• Conditions: Urinary Bladder Neoplasm
• Interventions: Device: Cellvizio dual band

• Registration Number: NCT02857634
• Lead Sponsor: Lille Catholic University

Brief Summary

Bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has improved tumor detection but with a high false positive rate. Indeed, the main limitation of the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for the diagnosis of tumors bladders.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients having 18 years old or more
• Patients with a bladder carcinoma and with indication of tumor resection under Hexvix procedure.
• Patients giving consent to participate in the study

Exclusion Criteria

-No consent to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder tumor resection	Cellvizio dual band	-

Primary Outcome Measures

Name	Time	Method
Determination of the nucleo-cytoplasmic ratio of cells	at inclusion	In order to perform comparison between benign versus malignant cytology, significant differences between cytoplasmic areas and nuclear areas will be determine to stablish a value of nucleo-cytoplasmic ratio

Secondary Outcome Measures

Name	Time	Method
Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology	through the study completion, an average of 6 months

Trial Locations

Locations (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille; 🇫🇷 Lomme, Nord, France