DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections
NCT ID: NCT02185170
Last Updated: 2015-09-22
Study Results
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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TERMINATED
NA
5 participants
INTERVENTIONAL
2014-07-31
2015-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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.
Trans-urethral resection
All subjects of the study are going to have a trans-urethral resection of prostate.
Use of the FEMTO-ST institute medical device
The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
Use of the Light-CT scanner
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.
Use of the FEMTO-ST institute medical device
The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
Use of the Light-CT scanner
The Light-CT Scanner is use in the tissue structural observation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Laboratoire TIMC-IMAG
OTHER
FEMTO-ST Institute
UNKNOWN
LLTech laboratory
UNKNOWN
Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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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
Countries
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Related Links
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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
Other Identifiers
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DCIC 12 03
Identifier Type: -
Identifier Source: org_study_id
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