Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

University Hospital, Grenoble2 sites in 1 country8 target enrollmentMay 11, 2017

ConditionsCancer Prostate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer Prostate
Sponsor: University Hospital, Grenoble
Enrollment: 8
Locations: 2
Primary Endpoint: 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).
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

/ the FEMTO-ST institute medical device,
/ the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Detailed Description

For this protocol, 12 patients will be included.

Registry

clinicaltrials.gov

Start Date

May 11, 2017

End Date

January 8, 2019

Last Updated

7 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

University Hospital, Grenoble

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Time Frame: 14 months

Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.

Secondary Outcomes

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)