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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02185170
• Other study ID #: DCIC 12 03
• Status: Terminated
• Phase: N/A
• First received: June 23, 2014
• Last updated: September 21, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.
• Use of the Light-CT scanner
The Light-CT Scanner is use in the tissue structural observation

Locations

Country	Name	City	State
France	Grenoble University Hospital, Urology and Anatomopathology Department	Grenoble

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Center, Technological Innovation (Grenoble and Besancon), FEMTO-ST Institute, LLTech laboratory, TIMC-IMAG - DyCTiM, TIMC-IMAG - GMCAO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Fluorescence measurements mean.	Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.	1 day	No
Secondary	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	No

External Links

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