Clinical trial NCT02800473: Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection
Official title: Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder cancer
Hexvix
Bimodal Endoscopic Imager
Cystoscopy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

Detailed description: An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patient with suspicion of a bladder cancer or a suspected recurrence of a bladder cancer
* Cytological and bacteriological examination of urine culture negative
* Patient must be affiliated to a social security system
* Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion Criteria:

* Age \< 18 years
* Bladder infection in progress and untreated
* Hemorrhage
* Urethral stenosis
* Contraindication for a cystoscopy examination
* Contraindication to administration of Hexvix (porphyria, hypersensitivity to hexylaminolévulinate or excipient of Hexvix (disodium phosphate dihydrate, potassium dihydrogen phosphate)
* Pregnant or breast feeding females
* Patients deprived of liberty or under supervision

Primary outcomes:
measure: Ergonomic comparaison of the two devices
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of performing time
timeFrame: 1 day
measure: Quality assessment of image
timeFrame: 1 day
measure: Quality assessment of device evaluation
timeFrame: 1 day
measure: Evaluation of recording capacity of the video sequences to perform real-time image mosaics
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: ESCHWEGE PASCAL, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amouroux M, Salleron J, Huin-Schohn C, Ali S, Berthaud S, Rizo P, Schneider S, Vever-Bizet C, Bourg-Heckly G, Guillemin F, Le Coupanec P, Galbrun E, Daouk J, Daul C, Blondel W, Eschwege P. Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer. J Opt Soc Am A Opt Image Sci Vis. 2019 Nov 1;36(11):C62-C68. doi: 10.1364/JOSAA.36.000C62.