Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

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.

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