Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE) (PERSEE)

February 10, 2016 updated by: Institut Mutualiste Montsouris

Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study involves several innovations including :

  • the robotization of the confocal miniprobe for a better an d more precise handling of the probe
  • the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
  • the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Mutualiste Montsouris Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
  • patient able to give written informed consent

Exclusion Criteria:

  • allergy to fluorescein
  • allergy to patented blue
  • allergy to ICG
  • previous life-threatening allergic reactions and known hypersensitivity
  • pregnancy or breast-feeding
  • history of cardio-pulmonary disease (including bronchial asthma)
  • restricted renal function
  • patient under a beta-blockers treatment
  • patient who cannot give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: confocal laser endomicroscopy
confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs
Device: confocal laser endomicroscopy
probe-based and needle-based confocal laser endomicroscopy
Other Names:
  • Cellvizio
  • optical biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of participants with adverse events, their type and severity
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ease of manipulation of the robotized probe (grade 1 to 5)
Time Frame: 8 months
during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)
Time Frame: 8 months
during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication
8 months
number of interpretable images per organ, per contrast agent and per pathology
Time Frame: 8 months
each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Collaborators

Mauna Kea Technologies

Investigators

  • Principal Investigator: Brice GAYET, MD, Mutualiste Montsouris Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (ESTIMATE)

December 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKT-2013-PERSEE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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