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

Institut Mutualiste Montsouris

Status: Completed

Conditions: Cancer of Digestive System; Ovarian Cancer

Treatments: Device: confocal laser endomicroscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02312167

MKT-2013-PERSEE-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

confocal laser endomicroscopy

Experimental group

Description:

confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs

Treatment:

Device: confocal laser endomicroscopy