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

NCT01738217 | Completed Phase 1 DMC

• 2 other identifiers: HEPATOFLUOET12-066
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Intra-operative imaging; NIR Fluorescence; Liver surgery; Tumoral margins

Outcome Measures

Primary Outcomes (3)

• First step: assess the feasibility and the acceptability of Fluobeam

  * 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.

  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.

  During surgery on day 0

Secondary Outcomes (14)

• First step: assess the ability to visualize the fluorescent anatomical areas

  During surgery on day 0

• First step: Quantify the fluorescence

  After the surgery, on day 0

• First step: assess the ability to review saved data

  After the surgery, on day 0

• Second step: assess the ability to detect tumor lesions which were not previously known.

  During surgery on day 0

• Second step: assess the rate of modifications of the surgical plan.

  During surgery on day 0

Study Arms (1)

Fluobeam

EXPERIMENTAL

Procedure: Fluobeam

Interventions

Fluobeam PROCEDURE

Fluobeam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (22)

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  PMID: 19435621 RESULT

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Patrice Peyrat

  Centre Léon Bérard, LYON, FRANCE.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 30, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

FR (1)