Confocal Microscopy Dual Band in the Management of Bladder Cancer (HEXVISIO)

October 30, 2018 updated by: Lille Catholic University

Study of the Contribution of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lomme, Nord, France, 59462
        • Groupement des Hôpitaux de l'institut Catholique de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients following a tumor resection of the bladder

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bladder tumor resection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
through the study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Jean-Louis Bonnal, MD, Service d'Urologie, Groupement des hôpitaux de l'Institut Catholique de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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