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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Prostate Cancer

Treatments: Device: Use of the Light-CT scanner; Procedure: Trans-urethral resection; Device: Use of the FEMTO-ST institute medical device

Study type: Interventional

Funder types: Other

Identifiers

NCT02185170

DCIC 12 03

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Fluorescence assesment

Experimental group

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.

Treatment:

Device: Use of the Light-CT scanner

Procedure: Trans-urethral resection

Device: Use of the FEMTO-ST institute medical device