Confocal Microscopy Dual Band in the Management of Bladder Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord, 59462, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Determination of the nucleo-cytoplasmic ratio of cells

Time frame: 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 outcomes

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

Time frame: through the study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: HEXVISIO

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Aug 5, 2016
Registry last updated: Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed