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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01738217
First received: November 26, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Liver Neoplasms
Procedure: Fluobeam
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • First step: assess the feasibility and the acceptability of Fluobeam [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
    • 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

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First step: assess the ability to visualize the fluorescent anatomical areas [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
  • First step: Quantify the fluorescence [ Time Frame: After the surgery, on day 0 ] [ Designated as safety issue: No ]
    by using the images obtained during the surgery

  • First step: assess the ability to review saved data [ Time Frame: After the surgery, on day 0 ] [ Designated as safety issue: No ]
  • Second step: assess the ability to detect tumor lesions which were not previously known. [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
    Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis.

  • Second step: assess the rate of modifications of the surgical plan. [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
    Number of patients for whom the surgery would be modified after using Fluobeam.

  • Second step: assess the quality of the resection margins. [ Time Frame: After the surgery on day 0 ] [ Designated as safety issue: No ]
    It will be measured using the residual fluorescence and the pathology analysis

  • Second step: assess the depth limit of detection of the fluorescence. [ Time Frame: After the pathology analysis on day 0 ] [ Designated as safety issue: No ]
    It will be assessed after the anatomopathological analysis.

  • Second step: Quantify the fluorescence. [ Time Frame: After the surgery, on day 0 ] [ Designated as safety issue: No ]
    From images obtained during the surgery and from the sample analysed by a pathologist.

  • Second step: assess the number of asepsis due to Fluobeam [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
  • Third step: assess the ability to detect tumor lesions which were not previously known. [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
    Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis

  • Third step: quantify the fluorescence. [ Time Frame: After the surgery on day 0 ] [ Designated as safety issue: No ]
    From images obtained during the surgery and from the sample analysed by a pathologist.

  • Third step: assess the ability to administer two doses of ICG in the same patient [ Time Frame: On day 0 ] [ Designated as safety issue: No ]
    one before and one during the surgery (tumor detection and segment targeting respectively).

  • Third step: assess the number of asepsis due to Fluobeam [ Time Frame: During surgery on day 0 ] [ Designated as safety issue: No ]
  • Third step: assess the ability of the medical device to detect tumor lesions which were previously known. [ Time Frame: On day 0 ] [ Designated as safety issue: No ]
    Number of lesions seen on images before and during the surgery and detected by Fluobeam.


Estimated Enrollment: 46
Study Start Date: April 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluobeam Procedure: Fluobeam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738217

Contacts
Contact: Ellen BLANC +33 478 78 29 67 ellen.blanc@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
Lyon Cedex 08, France, 69373
Principal Investigator: Patrice Peyrat, MD         
Sub-Investigator: Michel RIVOIRE, MD         
Sub-Investigator: Aurélien DUPRE, MD         
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Patrice Peyrat Centre Léon Bérard, LYON, FRANCE.
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01738217     History of Changes
Other Study ID Numbers: HEPATOFLUO, ET12-066
Study First Received: November 26, 2012
Last Updated: January 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Leon Berard:
Intra-operative imaging
NIR Fluorescence
Liver surgery
Tumoral margins

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014