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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trans-urethral resection
Use of the FEMTO-ST institute medical device
Use of the Light-CT scanner
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate, Cancer, Medical Device, Fluorescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Grenoble University Hospital, Urology and Anatomopathology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescence assesment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Fluorescence measurements mean.
Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.
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

Full Information

First Posted
June 23, 2014
Last Updated
September 21, 2015
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire TIMC-IMAG, FEMTO-ST Institute, LLTech laboratory, Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
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1. Study Identification

Unique Protocol Identification Number
NCT02185170
Brief Title
DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections
Official Title
Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Results of 5 first patients show that chips' cauterization interferes the signal
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire TIMC-IMAG, FEMTO-ST Institute, LLTech laboratory, Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer, Medical Device, Fluorescence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluorescence assesment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Trans-urethral resection
Intervention Description
All subjects of the study are going to have a trans-urethral resection of prostate.
Intervention Type
Device
Intervention Name(s)
Use of the FEMTO-ST institute medical device
Intervention Description
The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
Intervention Type
Device
Intervention Name(s)
Use of the Light-CT scanner
Intervention Description
The Light-CT Scanner is use in the tissue structural observation
Primary Outcome Measure Information:
Title
Complete fluorescence measurement over each field of vision.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Complete fluorescence measurement over each field of vision.
Description
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.
Time Frame
1 day
Title
Quality criteria of the structure of tissue (ordinal qualitative variables).
Description
Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
Time Frame
1 day
Title
Fluorescence measurements mean.
Description
Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.
Time Frame
1 day
Title
Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides
Description
Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patient over 18 years old. Patient scheduled for trans-urethral resection of prostate with: prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age > 80 years old 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Descotes, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital, Urology and Anatomopathology Department
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.cic-it-grenoble.fr
Description
Website of the Grenoble Clinical Investigation Center - Technological Innovation
URL
http://www-timc.imag.fr/
Description
Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratory
URL
http://www.femto-st.fr/
Description
Website of FEMTO-ST

Learn more about this trial

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

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