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

NCT02185170 | Terminated

• 1 other identifier: DCIC 12 03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Medical Device; Fluorescence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complete fluorescence measurement over each field of vision.

  1 day

• Quality criteria of the structure of tissue (ordinal qualitative variables).

  1 day

• Fluorescence measurements mean.

  1 day

• Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides

  1 day

Study Arms (1)

Fluorescence assesment

EXPERIMENTAL

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; Device: Use of the FEMTO-ST institute medical device; Device: Use of the Light-CT scanner

Interventions

Trans-urethral resection PROCEDURE

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

Fluorescence assesment

Use of the FEMTO-ST institute medical device DEVICE

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

Fluorescence assesment

Use of the Light-CT scanner DEVICE

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

Fluorescence assesment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire TIMC-IMAG: collaborator
• FEMTO-ST Institute: collaborator
• LLTech laboratory: collaborator
• Clinical Investigation Center, Technological Innovation (Grenoble and Besancon): collaborator

Study Sites (1)

Grenoble University Hospital, Urology and Anatomopathology Department

Grenoble, 38043, France

Location

Related 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

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jean-Luc Descotes, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

FR (1)