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

NCT ID: NCT03157856

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2019-01-08

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.

Conditions

Cancer Prostate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental: fluorescence assessment

Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.

Fluorescence assessment

Intervention Type: 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.

Interventions

Fluorescence 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

TIMC-IMAG

OTHER

Sponsor Role: collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Luc Descotes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Grenoble Alpes University Hospital

Locations

Grenoble Alpes University Hospital - Urology department

Grenoble, , France

Grenoble Alpes University Hospital

Grenoble, , France

Countries

France

Other Identifiers

38RC17.019

Identifier Type: -

Identifier Source: org_study_id