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

NCT ID: NCT01738217

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

Liver Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Fluobeam

Group Type: EXPERIMENTAL

Fluobeam

Intervention Type: PROCEDURE

Interventions

Fluobeam

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice Peyrat

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, LYON, FRANCE.

Locations

Centre Léon Bérard

Lyon, , France

Countries

France

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Other Identifiers

ET12-066

Identifier Type: OTHER

Identifier Source: secondary_id

HEPATOFLUO

Identifier Type: -

Identifier Source: org_study_id