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

NCT ID: NCT02185170

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Trans-urethral resection

Intervention Type PROCEDURE

All subjects of the study are going to have a trans-urethral resection of prostate.

Use of the FEMTO-ST institute medical device

Intervention Type DEVICE

The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.

Use of the Light-CT scanner

Intervention Type DEVICE

The Light-CT Scanner is use in the tissue structural observation

Interventions

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Trans-urethral resection

All subjects of the study are going to have a trans-urethral resection of prostate.

Intervention Type PROCEDURE

Use of the FEMTO-ST institute medical device

The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.

Intervention Type DEVICE

Use of the Light-CT scanner

The Light-CT Scanner is use in the tissue structural observation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire TIMC-IMAG

OTHER

Sponsor Role collaborator

FEMTO-ST Institute

UNKNOWN

Sponsor Role collaborator

LLTech laboratory

UNKNOWN

Sponsor Role collaborator

Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc Descotes, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Grenoble University Hospital, Urology and Anatomopathology Department

Grenoble, , France

Site Status

Countries

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France

Related Links

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http://www.cic-it-grenoble.fr

Website of the Grenoble Clinical Investigation Center - Technological Innovation

http://www-timc.imag.fr/

Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratory

http://www.femto-st.fr/

Website of FEMTO-ST

Other Identifiers

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DCIC 12 03

Identifier Type: -

Identifier Source: org_study_id

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