Prostate Cancer
Conditions
Keywords
Prostate, Cancer, Medical Device, Fluorescence
Brief summary
The aim of this study is divided in 4 different steps: * the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging), * the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue, * the third step is to validate the use of: 1. the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue, 2. the Light-CT scanner use for tissue structural observation. * the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
Interventions
PROCEDURETrans-urethral resection
All subjects of the study are going to have a trans-urethral resection of prostate.
DEVICEUse of the FEMTO-ST institute medical device
The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
DEVICEUse of the Light-CT scanner
The Light-CT Scanner is use in the tissue structural observation
Sponsors
Laboratoire TIMC-IMAG
FEMTO-ST Institute
LLTech laboratory
Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patient over 18 years old. * Patient scheduled for trans-urethral resection of prostate with: 1. prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age \> 80 years old 2. a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level \> 50 ng/ml or an existing prostate cancer * Patient affiliated to social security or beneficiary of such a regime.
Exclusion criteria
* Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete fluorescence measurement over each field of vision. | 1 day | Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete fluorescence measurement over each field of vision. | 1 day | Determinate for the anti-PSMA antibody with R-Phycoerythrin tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol. |
| Quality criteria of the structure of tissue (ordinal qualitative variables). | 1 day | Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device. |
| Fluorescence measurements mean. | 1 day | Validate the medical device from FEMTO-ST institute for the detection of fluorescence signals on fresh prostatic tissue. |
| Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides | 1 day | Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation |
Countries
France
Outcome results
None listed