Clinical trial NCT01738217: Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery
Official title: Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Neoplasms
Keywords: Intra-operative imaging
NIR Fluorescence
Liver surgery
Tumoral margins
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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)

Primary outcomes:
measure: First step: assess the feasibility and the acceptability of Fluobeam
timeFrame: During surgery on day 0
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: 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.
timeFrame: During surgery on day 0
Secondary outcomes:
measure: First step: assess the ability to visualize the fluorescent anatomical areas
timeFrame: During surgery on day 0
measure: First step: Quantify the fluorescence
timeFrame: After the surgery, on day 0
measure: First step: assess the ability to review saved data
timeFrame: After the surgery, on day 0
measure: Second step: assess the ability to detect tumor lesions which were not previously known.
timeFrame: During surgery on day 0
measure: Second step: assess the rate of modifications of the surgical plan.
timeFrame: During surgery on day 0
measure: Second step: assess the quality of the resection margins.
timeFrame: After the surgery on day 0
measure: Second step: assess the depth limit of detection of the fluorescence.
timeFrame: After the pathology analysis on day 0
measure: Second step: Quantify the fluorescence.
timeFrame: After the surgery, on day 0
measure: Second step: assess the number of asepsis due to Fluobeam
timeFrame: During surgery on day 0
measure: Third step: assess the ability to detect tumor lesions which were not previously known.
timeFrame: During surgery on day 0
measure: Third step: quantify the fluorescence.
timeFrame: After the surgery on day 0
measure: Third step: assess the ability to administer two doses of ICG in the same patient
timeFrame: On day 0
measure: Third step: assess the number of asepsis due to Fluobeam
timeFrame: During surgery on day 0
measure: Third step: assess the ability of the medical device to detect tumor lesions which were previously known.
timeFrame: On day 0
Other outcomes:
Locations:
city: Lyon Cedex 08
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Léon Bérard, LYON, FRANCE.
name: Patrice Peyrat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aoki 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.
citation: Aoki 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.
citation: Barbare JC. Quantification de la fonction hépatique: Pourquoi et comment? John Libbey Eurotext. HEPATO-GASTRO.5(6):423-431,1998.
citation: Billingsley 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.
citation: Gotoh 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.
citation: Hamamatsu Photonics-Pulsion Medical System.PDE Photodynamic Eye. http://www.iht-ltd.com/pde-photodynamic-eye/
citation: Hamoui 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
citation: HAS.Guide ALD30-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer primitif du foie. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs
citation: HAS. Guide ALD-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer colorectal Adénocarcinome. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs
citation: Ishizawa T, Fukushima N, Shibahara J, Masuda K, Tamura S, Aoki T, Hasegawa K, Beck Y, Fukayama M, Kokudo N. Real-time identification of liver cancers by using indocyanine green fluorescent imaging. Cancer. 2009 Jun 1;115(11):2491-504. doi: 10.1002/cncr.24291.
citation: Ishizuka M, Kubota K, Kita J, Shimoda M, Kato M, Sawada T. Intraoperative observation using a fluorescence imaging instrument during hepatic resection for liver metastasis from colorectal cancer. Hepatogastroenterology. 2012 Jan-Feb;59(113):90-2. doi: 10.5754/hge11223.
citation: Jarnagin WR, Bach AM, Winston CB, Hann LE, Heffernan N, Loumeau T, DeMatteo RP, Fong Y, Blumgart LH. What is the yield of intraoperative ultrasonography during partial hepatectomy for malignant disease? J Am Coll Surg. 2001 May;192(5):577-83. doi: 10.1016/s1072-7515(01)00794-3.
citation: Morita Y, Sakaguchi T, Unno N, Shibasaki Y, Suzuki A, Fukumoto K, Inaba K, Baba S, Takehara Y, Suzuki S, Konno H. Detection of hepatocellular carcinomas with near-infrared fluorescence imaging using indocyanine green: its usefulness and limitation. Int J Clin Oncol. 2013 Apr;18(2):232-41. doi: 10.1007/s10147-011-0367-3. Epub 2011 Dec 27.
citation: O2View. ArteMIS Handheld Complete System. http://o2view.com/
citation: Pawlik TM, Scoggins CR, Zorzi D, Abdalla EK, Andres A, Eng C, Curley SA, Loyer EM, Muratore A, Mentha G, Capussotti L, Vauthey JN. Effect of surgical margin status on survival and site of recurrence after hepatic resection for colorectal metastases. Ann Surg. 2005 May;241(5):715-22, discussion 722-4. doi: 10.1097/01.sla.0000160703.75808.7d.
citation: Reuthebuch O, Haussler A, Genoni M, Tavakoli R, Odavic D, Kadner A, Turina M. Novadaq SPY: intraoperative quality assessment in off-pump coronary artery bypass grafting. Chest. 2004 Feb;125(2):418-24. doi: 10.1378/chest.125.2.418.
citation: Rivoire M.Diagnostiquer une tumeur du foie primitive et secondaire. http://cancero.unice.fr/sitelocal/disciplines/niveaudiscipline/cancerologie/numlecon151/leconimprim.pdf
citation: Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14.
citation: Société Française de Chirurgie Digestive (SFCD), Association de Chirurgie hépatobiliaire et de Transplantation Hépatique (ACHBT). Prise en charge des patients atteints de métastases hépatiques synchrones du cancer colorectal-Recommandations professionnelles-Synthèse. www.e-cancer.fr
citation: Takahashi M, Ishikawa T, Higashidani K, Katoh H. SPY: an innovative intra-operative imaging system to evaluate graft patency during off-pump coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):479-83. doi: 10.1016/j.icvts.2004.01.018.
citation: Weber SM, Jarnagin WR, DeMatteo RP, Blumgart LH, Fong Y. Survival after resection of multiple hepatic colorectal metastases. Ann Surg Oncol. 2000 Oct;7(9):643-50. doi: 10.1007/s10434-000-0643-3.
citation: Slim K, Blay JY, Brouquet A, Chatelain D, Comy M, Delpero JR, Denet C, Elias D, Flejou JF, Fourquier P, Fuks D, Glehen O, Karoui M, Kohneh-Shahri N, Lesurtel M, Mariette C, Mauvais F, Nicolet J, Perniceni T, Piessen G, Regimbeau JM, Rouanet P, sauvanet A, Schmitt G, Vons C, Lasser P, Belghiti J, Berdah S, Champault G, Chiche L, Chipponi J, Chollet P, De Baere T, Dechelotte P, Garcier JM, Gayet B, Gouillat C, Kianmanesh R, Laurent C, Meyer C, Millat B, Msika S, Nordlinger B, Paraf F, Partensky C, Peschaud F, Pocard M, Sastre B, Scoazec JY, Scotte M, Triboulet JP, Trillaud H, Valleur P. [Digestive oncology: surgical practices]. J Chir (Paris). 2009 May;146 Suppl 2:S11-80. doi: 10.1016/S0021-7697(09)72398-1. No abstract available. French.