Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection (CyPaM2)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: CyPaM2 (experimental); Device: Strorz (commercial)

Study type: Interventional

Funder types: Other

Identifiers

NCT02800473

2015-A01297-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental

Other group

Description:

Patients with a suspicion of a bladder cancer or suspected recurrence of bladder cancer will have a cystoscopy under their care. Patients will be randomized to know the order of carrying out cystoscopy with one or the other medical devices. 24 hours and 48 hours after the exam, a nurse will contact the patient to detect potential adverse effects

Treatment:

Device: CyPaM2 (experimental)

Device: Strorz (commercial)