Confocal Microscopy Dual Band in the Management of Bladder Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Bladder Neoplasm

Intervention / Treatment
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* Device: Cellvizio dual band


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder tumor resection<br> | Device: Cellvizio dual band<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology |  | through the study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Bladder cancer, diagnosis, Cellvizio Dual Band