Bladder Cancer
Conditions
Keywords
Bladder cancer, Hexvix, Bimodal Endoscopic Imager, Cystoscopy
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.
Interventions
DEVICEStrorz (commercial)
DEVICECyPaM2 (experimental)
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ergonomic comparaison of the two devices | 1 day | Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of performing time | 1 day | Performing time of medical examination with both devices will be evaluated and compared |
| Quality assessment of image | 1 day | Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire. |
| Quality assessment of device evaluation | 1 day | Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire |
| Evaluation of recording capacity of the video sequences to perform real-time image mosaics | 1 day | Recording capacity of the video sequences to perform real-time image mosaics will be assessed by the physician using a self-questionnaire |
Countries
France
Outcome results
None listed