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Results obtained on the first 8 patients shown an expected glandular membrane specific labeling associated with non-specific labeling of fibro-muscular tissue.
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| Name | Class |
|---|---|
| TIMC-IMAG | OTHER |
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
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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:
For this protocol, 12 patients will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: fluorescence assessment | Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope. | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope. | 14 months |
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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.
Exclusion Criteria:
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Patient with indication for radical prostatectomy
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| Name | Affiliation | Role |
|---|---|---|
| Jean Luc Descotes, MD, PhD | Grenoble Alpes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble Alpes University Hospital - Urology department | Grenoble | 38043 | France | |||
| Grenoble Alpes University Hospital |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Grenoble |
| 38043 |
| France |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |