Confocal Microscopy Dual Band in the Management of Bladder Cancer

Urinary Bladder Neoplasm Clinical Trial

— HEXVISIO  

Official title:

Study of the Contribution of Confocal Microscopy Dual Band in the Management of Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857634
• Other study ID #: RC-P0035
• Status: Completed
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

Device:
• Cellvizio dual band
Using fluorescence cytoscopy, lesions in the bladder will be resected. The samples will be immediately observed in order to keep the fluorescein effect under confocal microscopy (Cellvizio dual band). After confocal microscopy samples will be fixed in formalin and prepare for the pathologist that will confirm the diagnosis. The Cellvizio system can be used to observe a resected sample ex vivo, offering a cellular-level view of internal tissue. This technique allows the visualization of the microstructure of the tissue in real-time which may improve targeted sampling, provide earlier disease detection and help patient management. The Cellvizio system includes miniaturized optics, optical fiber bundles, high-speed scanning and advanced image processing components.

Locations

Country	Name	City	State
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lomme	Nord

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the nucleo-cytoplasmic ratio of cells	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	at inclusion
Secondary	Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology		through the study completion, an average of 6 months