DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections

Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.

The aim of this study is divided in 4 different steps:

• the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
• the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,

• the third step is to validate the use of:

  1. the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
  2. the Light-CT scanner use for tissue structural observation.
• the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Trans-urethral resection; Device: Use of the FEMTO-ST institute medical device; Device: Use of the Light-CT scanner

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University Hospital, Urology and Anatomopathology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male patient over 18 years old.

• Patient scheduled for trans-urethral resection of prostate with:

  1. prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age > 80 years old
  2. a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level > 50 ng/ml or an existing prostate cancer
• Patient affiliated to social security or beneficiary of such a regime.

Exclusion Criteria:

• Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fluorescence assesment; All patients undergo a transurethral resection. There are four different steps in the study: the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,; the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,; the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,; the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.

Procedure: Trans-urethral resection; All subjects of the study are going to have a trans-urethral resection of prostate.; Device: Use of the FEMTO-ST institute medical device; The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.; Device: Use of the Light-CT scanner; The Light-CT Scanner is use in the tissue structural observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete fluorescence measurement over each field of vision.	Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete fluorescence measurement over each field of vision.	Determinate for the anti-PSMA antibody with R-Phycoerythrin tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.	1 day
Quality criteria of the structure of tissue (ordinal qualitative variables).	Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.	1 day
Fluorescence measurements mean.	Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.	1 day
Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides	Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Laboratoire TIMC-IMAG; FEMTO-ST Institute; LLTech laboratory; Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
• Investigators: Principal Investigator: Jean-Luc Descotes, MD, University Hospital, Grenoble

Publications and helpful links

Helpful Links

• Website of the Grenoble Clinical Investigation Center - Technological Innovation
• Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratory
• Website of FEMTO-ST
• Website of the Grenoble Hospital University Urology Service

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Prostate; Medical Device; Fluorescence
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: DCIC 12 03