Cancer Prostate
Conditions
Keywords
Fluorescence imaging technique, Biopsies from resected prostate, Medical device
Brief summary
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by: 1. / the FEMTO-ST institute medical device, 2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.
Detailed description
For this protocol, 12 patients will be included.
Interventions
OTHERFluorescence assessment
All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.
Sponsors
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male patient over 18 years old * patient with indication for radical prostatectomy * patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate. * patient affiliated to French social security system or equivalent * patient who have signed a non-opposition form
Exclusion criteria
* patient with contraindication to radical prostatectomy * patient with remedial prostatectomy * patient with normal preoperative MRI or with absence of tumoral area * patient with history of hormonal therapy * person deprived of freedom by judicial or administrative decision * person under legal protection * person hospitalized for psychiatric care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard). | 14 months | Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard). | 14 months | Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope. |
Countries
France
Outcome results
None listed