Confocal Microscopy Dual Band in the Management of Bladder Cancer

NCT02857634 | Completed

• 1 other identifier: RC-P0035
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Neoplasm

Keywords

Urinary Bladder cancer; diagnosis; Cellvizio Dual Band

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of neoplastic lesions identified by Cellvizio compared to number of lesions identified by pathology

  through the study completion, an average of 6 months

Study Arms (1)

Bladder tumor resection

Device: Cellvizio dual band

Interventions

Cellvizio dual band DEVICE

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.

Bladder tumor resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients following a tumor resection of the bladder

You may qualify if:

• 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

You may not qualify if:

• No consent to participate in the study

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord, 59462, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Using PDD, urothelial lesions will be resected. The samples will be immediately investigated effect under confocal microscopy (Cellvizio dual band) in order to keep the fluoresceine effect. After confocal microscopy samples will be fixed in formalin and prepare for the pathologist that will confirm the diagnosis.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Louis Bonnal, MD

  Service d'Urologie, Groupement des hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)