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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Procedure: Fluobeam


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluobeam<br> | Procedure: Fluobeam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First step: assess the ability to visualize the fluorescent anatomical areas |  | During surgery on day 0 | 
| First step: Quantify the fluorescence | by using the images obtained during the surgery | 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. | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis. | During surgery on day 0 | 
| Second step: assess the rate of modifications of the surgical plan. | Number of patients for whom the surgery would be modified after using Fluobeam. | During surgery on day 0 | 
| Second step: assess the quality of the resection margins. | It will be measured using the residual fluorescence and the pathology analysis | After the surgery on day 0 | 
| Second step: assess the depth limit of detection of the fluorescence. | It will be assessed after the anatomopathological analysis. | After the pathology analysis on day 0 | 
| Second step: Quantify the fluorescence. | From images obtained during the surgery and from the sample analysed by a pathologist. | After the surgery, on day 0 | 
| Second step: assess the number of asepsis due to Fluobeam |  | During surgery on day 0 | 
| Third step: assess the ability to detect tumor lesions which were not previously known. | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis | During surgery on day 0 | 
| Third step: quantify the fluorescence. | From images obtained during the surgery and from the sample analysed by a pathologist. | After the surgery on day 0 | 
| Third step: assess the ability to administer two doses of ICG in the same patient | one before and one during the surgery (tumor detection and segment targeting respectively). | On day 0 | 
| Third step: assess the number of asepsis due to Fluobeam |  | During surgery on day 0 | 
| Third step: assess the ability of the medical device to detect tumor lesions which were previously known. | Number of lesions seen on images before and during the surgery and detected by Fluobeam. | On day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-operative imaging, NIR Fluorescence, Liver surgery, Tumoral margins