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

Ovarian Cancer Clinical Trial

— PERSEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312167
• Other study ID #: MKT-2013-PERSEE-01
• Status: Completed
• Phase: N/A
• First received: November 28, 2014
• Last updated: February 10, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Digestive System
• Digestive System Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Device:
• confocal laser endomicroscopy
probe-based and needle-based confocal laser endomicroscopy

Locations

Country	Name	City	State
France	Mutualiste Montsouris Institute	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Mauna Kea Technologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)	during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication	8 months	No
Other	number of interpretable images per organ, per contrast agent and per pathology	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	No
Primary	The number of participants with adverse events, their type and severity		8 months	Yes
Secondary	The ease of manipulation of the robotized probe (grade 1 to 5)	during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device	8 months	No