Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluobeam | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluobeam
- interventionNames
- Procedure: Fluobeam
Primary outcomes (3)
- measure
- First step: assess the feasibility and the acceptability of Fluobeam
- timeFrame
- During surgery on day 0
- description
- * 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
- measure
- 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.
- timeFrame
- During surgery on day 0
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (22)
- BACKGROUNDAoki T, Murakami M, Yasuda D, Shimizu Y, Kusano T, Matsuda K, Niiya T, Kato H, Murai N, Otsuka K, Kusano M, Kato T. Intraoperative fluorescent imaging using indocyanine green for liver mapping and cholangiography. J Hepatobiliary Pancreat Sci. 2010 Sep;17(5):590-4. doi: 10.1007/s00534-009-0197-0. Epub 2009 Oct 21. PMID 19844652
- BACKGROUNDAoki T, Yasuda D, Shimizu Y, Odaira M, Niiya T, Kusano T, Mitamura K, Hayashi K, Murai N, Koizumi T, Kato H, Enami Y, Miwa M, Kusano M. Image-guided liver mapping using fluorescence navigation system with indocyanine green for anatomical hepatic resection. World J Surg. 2008 Aug;32(8):1763-7. doi: 10.1007/s00268-008-9620-y. PMID 18543027
- BACKGROUNDBarbare JC. Quantification de la fonction hépatique: Pourquoi et comment? John Libbey Eurotext. HEPATO-GASTRO.5(6):423-431,1998.
- BACKGROUNDBillingsley KG, Jarnagin WR, Fong Y, Blumgart LH. Segment-oriented hepatic resection in the management of malignant neoplasms of the liver. J Am Coll Surg. 1998 Nov;187(5):471-81. doi: 10.1016/s1072-7515(98)00231-2. PMID 9809562
- BACKGROUNDGotoh K, Yamada T, Ishikawa O, Takahashi H, Eguchi H, Yano M, Ohigashi H, Tomita Y, Miyamoto Y, Imaoka S. A novel image-guided surgery of hepatocellular carcinoma by indocyanine green fluorescence imaging navigation. J Surg Oncol. 2009 Jul 1;100(1):75-9. doi: 10.1002/jso.21272. PMID 19301311
- BACKGROUNDHamamatsu Photonics-Pulsion Medical System.PDE Photodynamic Eye. http://www.iht-ltd.com/pde-photodynamic-eye/
- BACKGROUNDHamoui M; Marchand JP. Boutabrine H. Navarro F. L'évaluation préopératoire du risque d'insuffisance hépatocellulaire lors des résections hépatiques sur foie cirrhotique. John Libbey Eurotext.HEPATO-GASTRO. 16(1):11-19, 2009
- BACKGROUNDHAS.Guide ALD30-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer primitif du foie. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs