DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections

Study Overview
=================
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: the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue, 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.

Official Title
-----------------
Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Trans-urethral resection
* Device: Use of the FEMTO-ST institute medical device
* Device: Use of the Light-CT scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patient over 18 years old. Patient scheduled for trans-urethral resection of prostate with: prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age > 80 years old 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence assesment<br>All patients undergo a transurethral resection. There are four different steps in the study: the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain, the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol, the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device, the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner. | Procedure: Trans-urethral resection<br>* All subjects of the study are going to have a trans-urethral resection of prostate.<br>Device: Use of the FEMTO-ST institute medical device<br>* The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.<br>Device: Use of the Light-CT scanner<br>* The Light-CT Scanner is use in the tissue structural observation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete fluorescence measurement over each field of vision. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete fluorescence measurement over each field of vision. | 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. | 1 day | 
| Quality criteria of the structure of tissue (ordinal qualitative variables). | Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device. | 1 day | 
| Fluorescence measurements mean. | Validate the medical device from FEMTO-ST institute for the detection of fluorescence signals on fresh prostatic tissue. | 1 day | 
| Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides | Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, Medical Device, Fluorescence