Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery

NCT ID: NCT03561857

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2020-06-30

Brief Summary

This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.

Detailed Description

Prostate cancer is one of the most diagnosed cancer in men. Several treatments are available depending on patient's clinical features. When the cancer is localised or locally advanced, one of the possible treatment is Radical Prostatectomy. A risk of that procedure is the incomplete removal of cancer tissues due to the presence of cancer cells within the resection margin. A histological analysis of the resected prostate allows to assess surgical margins. If cancer cells comes out to the edges of the removed tissue, it is called Positive Surgical Margin (PSM). Several studies showed that PSMs are more frequent in case of extra-prostatic extensions of the cancer and are correlated with biochemical recurrence.

A study conducted on 21 patients scheduled for Robotic-Assisted Radical Prostatectomy has already demonstrated the feasibility of the intra-operative observation of microscopic features of prostatic and periprostatic tissues in vivo and ex vivo with the Cellvizio® 100 Series system combined with the CelioFlex™ probe.

The main objective of the study is to assess the feasibility and safety of pCLE technology during radical prostatectomy (RP) and to assess the diagnostic performance of pCLE technology for the definition of the resection margins.

This method could be used to guide surgeons during nerve sparing surgery and provide real-time feedback for adequate dissection of NVB. As well, ex vivo characterisation of benign and cancerous glandular structures could provide an efficient and rapid method for intra-operative surgical margin assessment

The study is divided in 2 parts:

1. Ex vivo study

An ex vivo study will be carried out on 15 firsts prostate specimens for pathologist training and generation of ex vivo pCLE images atlas.

2. In vivo study

Prior to pCLE analysis, a contrast agent (Fluorescein) will be administered:

• by intravenous injection in each prostatic pedicles before their ligation
• topically, after NVB dissection, in a spray solution through a catheter inserted in an assistant trocar or with a soaked gauze.

The Cellvizio will be used during the NVB dissection to acquire in vivo images and sequences of prostatic tissues.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Confocal Laser Endomicroscopy

All included patients will undergo probe-based Confocal Laser Endomicroscopy during Robotic-Assisted Radical Prostatectomy (RARP) or Laparoscopic Radical Prostatectomy (LRP)

Group Type: EXPERIMENTAL

Confocal Laser Endomicroscopy

Intervention Type: DEVICE

The study is divided in 2 parts.

1. Ex vivo study

• Prostate specimens will be stained using Fluorescein
• Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired.

2. In vivo study

• Intravenous injection of contrast agent
• pCLE imaging every 5mm of the NVB dissection zone.

Interventions

Confocal Laser Endomicroscopy

The study is divided in 2 parts.

1. Ex vivo study

• Prostate specimens will be stained using Fluorescein
• Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired.

2. In vivo study

• Intravenous injection of contrast agent
• pCLE imaging every 5mm of the NVB dissection zone.

Intervention Type: DEVICE

Other Intervention Names

probe-based Confocal Laser Endomicroscopy; CelioFlex probe; Cellvizio 100 series; pCLE

Eligibility Criteria

Inclusion Criteria

• Over 18 years
• Localised or locally advanced prostate cancer
• Agreement given for Radical Prostatectomy
• Not eligible or refusing an active surveillance protocol
• having given its signed informed consent

Exclusion Criteria

• Under 18 years
• Previously treated for PCa (hormones, EBRT, focal treatments)
• Surgical history of BPH treatment
• Known allergy to Fluorescein

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mauna Kea Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Barret, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, , France

Site Status: NOT_YET_RECRUITING

Institut Mutualiste Montsouris

Paris, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Alexandre Colau, MD

Role: primary

Eric Barret, MD

Role: primary

eric.barret@imm.fr

01 56 61 62 63

Other Identifiers

2018-A01242-53

Identifier Type: OTHER

Identifier Source: secondary_id

MKT-2018-PERSEE-02

Identifier Type: -

Identifier Source: org_study_id