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


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Verified May 2017 by University Hospital, Grenoble

Sponsor:

Collaborators:

TIMC-IMAG

Clinical Investigation Centre for Innovative Technology Network

Information provided by (Responsible Party):

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT03157856

First received: May 15, 2017

Last updated: May 15, 2017

Last verified: May 2017

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.

Cancer Prostate Other: Fluorescence assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 12
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Experimental: fluorescence assessment

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

Other: 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 preleved from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.

For this protocol, 12 patients will be included.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Patient with indication for radical prostatectomy

Inclusion Criteria:

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03157856

Grenoble Alpes University Hospital – Urology department
Grenoble, France, 38043
Grenoble Alpes University Hospital
Grenoble, France, 38043
Contact: Jean Luc Descotes, MD, PhD    33 476 765 922    JLDescotes@chu-grenoble.fr   
Contact: Isabelle Boudry, PhD    33 476 766 645    iboudry@chu-grenoble.fr   
Sub-Investigator: Jean Alexandre Long, MD         
Sub-Investigator: Gaelle Fiard, MD         

University Hospital, Grenoble

TIMC-IMAG

Clinical Investigation Centre for Innovative Technology Network

Principal Investigator: Jean Luc Descotes, MD, PhD Grenoble Alpes University Hospital

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03157856     History of Changes
Other Study ID Numbers: 38RC17.019
Study First Received: May 15, 2017
Last Updated: May 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:

Fluorescence imaging technique
Biopsies from resected prostate
Medical device

ClinicalTrials.gov processed this record on May 17, 2017