NCT01738217

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Fluobeam

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2012-11-30
• Last updated: 2015-07-08

Locations

1 site across 1 country: France