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

Terminated

• Conditions: Cancer Prostate
• Interventions: Other: Fluorescence assessment

• Registration Number: NCT03157856
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2017-05-11
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Primary Completion: 2018-10-07
• Status Verified: 2019-01
• Study Completion: 2019-01-08
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: fluorescence assessment	Fluorescence assessment	Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Grenoble Alpes University Hospital - Urology department; 🇫🇷 Grenoble, France

Grenoble Alpes University Hospital; 🇫🇷 Grenoble, France