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

NCT03157856 | Terminated

• 1 other identifier: 38RC17.019
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Cancer Prostate

Keywords

Fluorescence imaging technique; Biopsies from resected prostate; Medical device

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Experimental: fluorescence assessment

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

Other: Fluorescence assessment

Interventions

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.

Experimental: fluorescence assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with indication for radical prostatectomy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• TIMC-IMAG: collaborator
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (2)

Grenoble Alpes University Hospital - Urology department

Grenoble, 38043, France

Location

Grenoble Alpes University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jean Luc Descotes, MD, PhD

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 11, 2017
• Primary Completion: October 7, 2018
• Study Completion: January 8, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)