Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

Cancer Prostate Clinical Trial

— Bio-Prost  

Official title:

Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03157856
• Other study ID #: 38RC17.019
• Status: Terminated
• Start date: May 11, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

1. / the FEMTO-ST institute medical device,

2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Description:

For this protocol, 12 patients will be included.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 8, 2019
• Est. primary completion date: October 7, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male patient over 18 years old

• patient with indication for radical prostatectomy

• patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.

• patient affiliated to French social security system or equivalent

• patient who have signed a non-opposition form

Exclusion Criteria:

• patient with contraindication to radical prostatectomy

• patient with remedial prostatectomy

• patient with normal preoperative MRI or with absence of tumoral area

• patient with history of hormonal therapy

• person deprived of freedom by judicial or administrative decision

• person under legal protection

• person hospitalized for psychiatric care.

Related Conditions & MeSH terms

• Cancer Prostate

Intervention

Other:
• Fluorescence assessment
All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble
France	Grenoble Alpes University Hospital - Urology department	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).	Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.	14 months
Secondary	Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).	Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.	14 months