Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery (HEPATOFLUO)

July 7, 2015 updated by: Centre Leon Berard

Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking

This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.

This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:

  • Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
  • Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,

  • Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.

    3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.

Patients will be followed during 4 weeks after the surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 1

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
      • Lyon Cedex 08, France, 69373
        • Centre Leon Berard

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:

  • Adult patient
  • Affected of hepatic cancerous lesions whatever they are
  • Requiring a one or two steps hepatectomy by laparotomy
  • ECOG performance status (PS)≤ 2
  • Mandatory affiliation to health security insurance
  • Written informed consent

Exclusion Criteria:

  • With a contraindication or hypersensitivity to ICG administration in medical history
  • Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
  • Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
  • Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluobeam
Procedure: Fluobeam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First step: assess the feasibility and the acceptability of Fluobeam
Time Frame: During surgery on day 0
  • The ability to detect fluorescence
  • The ability to investigate the mobilized parenchyma
  • The ability to use the medical device following requested asepsis procedures
  • Surgeon satisfaction
  • Nurse satisfaction
During surgery on day 0
Second step: assess the rate of patients in whom, all of the lesions (superficial/deep) will be detected by means of the Fluobeam medical device in peroperative or in postoperative.
Time Frame: During surgery on day 0
During surgery on day 0
Third step: assess the rate of patients in whom, among the 7 liver segments, the surgeon will be able to selectively target a predefined area.
Time Frame: During surgery on day 0
During surgery on day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First step: assess the ability to visualize the fluorescent anatomical areas
Time Frame: During surgery on day 0
During surgery on day 0
First step: Quantify the fluorescence
Time Frame: After the surgery, on day 0
by using the images obtained during the surgery
After the surgery, on day 0
First step: assess the ability to review saved data
Time Frame: After the surgery, on day 0
After the surgery, on day 0
Second step: assess the ability to detect tumor lesions which were not previously known.
Time Frame: During surgery on day 0
Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis.
During surgery on day 0
Second step: assess the rate of modifications of the surgical plan.
Time Frame: During surgery on day 0
Number of patients for whom the surgery would be modified after using Fluobeam.
During surgery on day 0
Second step: assess the quality of the resection margins.
Time Frame: After the surgery on day 0
It will be measured using the residual fluorescence and the pathology analysis
After the surgery on day 0
Second step: assess the depth limit of detection of the fluorescence.
Time Frame: After the pathology analysis on day 0
It will be assessed after the anatomopathological analysis.
After the pathology analysis on day 0
Second step: Quantify the fluorescence.
Time Frame: After the surgery, on day 0
From images obtained during the surgery and from the sample analysed by a pathologist.
After the surgery, on day 0
Second step: assess the number of asepsis due to Fluobeam
Time Frame: During surgery on day 0
During surgery on day 0
Third step: assess the ability to detect tumor lesions which were not previously known.
Time Frame: During surgery on day 0
Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis
During surgery on day 0
Third step: quantify the fluorescence.
Time Frame: After the surgery on day 0
From images obtained during the surgery and from the sample analysed by a pathologist.
After the surgery on day 0
Third step: assess the ability to administer two doses of ICG in the same patient
Time Frame: On day 0
one before and one during the surgery (tumor detection and segment targeting respectively).
On day 0
Third step: assess the number of asepsis due to Fluobeam
Time Frame: During surgery on day 0
During surgery on day 0
Third step: assess the ability of the medical device to detect tumor lesions which were previously known.
Time Frame: On day 0
Number of lesions seen on images before and during the surgery and detected by Fluobeam.
On day 0

Collaborators and Investigators

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

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Patrice Peyrat, Centre Léon Bérard, LYON, FRANCE.

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

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPATOFLUO
  • ET12-066 (Other Identifier: Sponsor Number)

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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