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

NCT01738217 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-07-08

No results posted yet for this study

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

PROCEDURE

Fluobeam

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Patrice Peyrat · Centre Léon Bérard, LYON, FRANCE.

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738217 on ClinicalTrials.gov