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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738217
First Posted: November 30, 2012
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Leon Berard
  Purpose

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.


Condition Intervention Phase
Liver Neoplasms Procedure: Fluobeam Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • First step: assess the feasibility and the acceptability of Fluobeam [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: During surgery on day 0 ]

Secondary Outcome Measures:
  • First step: assess the ability to visualize the fluorescent anatomical areas [ Time Frame: During surgery on day 0 ]
  • First step: Quantify the fluorescence [ Time Frame: After the surgery, on day 0 ]
    by using the images obtained during the surgery

  • First step: assess the ability to review saved data [ Time Frame: After the surgery, on day 0 ]
  • Second step: assess the ability to detect tumor lesions which were not previously known. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: After the pathology analysis on day 0 ]
    It will be assessed after the anatomopathological analysis.

  • Second step: Quantify the fluorescence. [ Time Frame: After the surgery, on day 0 ]
    From images obtained during the surgery and from the sample analysed by a pathologist.

  • Second step: assess the number of asepsis due to Fluobeam [ Time Frame: During surgery on day 0 ]
  • Third step: assess the ability to detect tumor lesions which were not previously known. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During surgery on day 0 ]
  • Third step: assess the ability of the medical device to detect tumor lesions which were previously known. [ Time Frame: On day 0 ]
    Number of lesions seen on images before and during the surgery and detected by Fluobeam.


Enrollment: 48
Study Start Date: April 2013
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluobeam Procedure: Fluobeam

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738217


Locations
France
Centre Léon Bérard
Lyon Cedex 08, France, 69373
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Patrice Peyrat Centre Léon Bérard, LYON, FRANCE.
  More Information

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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.
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.
Barbare JC. Quantification de la fonction hépatique: Pourquoi et comment? John Libbey Eurotext. HEPATO-GASTRO.5(6):423-431,1998.
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.
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.
Hamamatsu Photonics-Pulsion Medical System.PDE Photodynamic Eye. http://www.iht-ltd.com/pde-photodynamic-eye/
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
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
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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.
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.
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.
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.
O2View. ArteMIS Handheld Complete System. http://o2view.com/
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.
Reuthebuch O, Häussler 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.
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Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Löwik 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. Review.
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01738217     History of Changes
Other Study ID Numbers: HEPATOFLUO
ET12-066 ( Other Identifier: Sponsor Number )
First Submitted: November 26, 2012
First Posted: November 30, 2012
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by Centre Leon Berard:
Intra-operative imaging
NIR Fluorescence
Liver surgery
Tumoral margins

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases


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