Liver Neoplasms
Conditions
Keywords
Intra-operative imaging, NIR Fluorescence, Liver surgery, Tumoral margins
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.
Interventions
PROCEDUREFluobeam
Sponsors
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| First step: assess the feasibility and the acceptability of Fluobeam | During surgery on day 0 | * 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 |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second step: assess the ability to detect tumor lesions which were not previously known. | During surgery on day 0 | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis. |
| Second step: assess the rate of modifications of the surgical plan. | During surgery on day 0 | Number of patients for whom the surgery would be modified after using Fluobeam. |
| Second step: assess the quality of the resection margins. | After the surgery on day 0 | It will be measured using the residual fluorescence and the pathology analysis |
| Second step: assess the depth limit of detection of the fluorescence. | After the pathology analysis on day 0 | It will be assessed after the anatomopathological analysis. |
| Second step: Quantify the fluorescence. | After the surgery, on day 0 | From images obtained during the surgery and from the sample analysed by a pathologist. |
| First step: assess the ability to visualize the fluorescent anatomical areas | During surgery on day 0 | — |
| Third step: assess the ability to detect tumor lesions which were not previously known. | During surgery on day 0 | Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis |
| Third step: quantify the fluorescence. | After the surgery on day 0 | From images obtained during the surgery and from the sample analysed by a pathologist. |
| Third step: assess the ability to administer two doses of ICG in the same patient | On day 0 | one before and one during the surgery (tumor detection and segment targeting respectively). |
| 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. | On day 0 | Number of lesions seen on images before and during the surgery and detected by Fluobeam. |
| Second step: assess the number of asepsis due to Fluobeam | During surgery on day 0 | — |
| First step: Quantify the fluorescence | After the surgery, on day 0 | by using the images obtained during the surgery |
| First step: assess the ability to review saved data | After the surgery, on day 0 | — |
Countries
France
Outcome results
None listed