Liver NeoplasmsPhase 1/2HEPATOFLUONCT01738217
Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery
A Phase 1/2 study testing Fluobeam in people with Liver Neoplasms, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Fluobeam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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
- Liver Neoplasms
- Being tested
- Fluobeam
- Keywords
- Intra-operative imaging, NIR Fluorescence, Liver surgery, Tumoral margins
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluobeamProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fluobeam | Experimental | Not described Receives: Procedure: Fluobeam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: During surgery on day 0
Secondary outcomes (14)
First step: assess the ability to visualize the fluorescent anatomical areas
Measured: During surgery on day 0
First step: Quantify the fluorescence
by using the images obtained during the surgery
Measured: After the surgery, on day 0
First step: assess the ability to review saved data
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: After the surgery, on day 0
Second step: assess the number of asepsis due to Fluobeam
Measured: 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
Measured: During surgery on day 0
Third step: quantify the fluorescence.
From images obtained during the surgery and from the sample analysed by a pathologist.
Measured: 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).
Measured: On day 0
Third step: assess the number of asepsis due to Fluobeam
Measured: 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.
Measured: On day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice Peyrat, Principal investigator, Centre Léon Bérard, LYON, FRANCE.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738217
- Sponsor's protocol ID
- HEPATOFLUO
- Other IDs
- ET12-066
- Acronym
- HEPATOFLUO
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19844652Aoki 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.
PubMed 18543027Barbare 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. doi: 10.1016/s1072-7515(98)00231-2.
PubMed 9809562Gotoh 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.
PubMed 19301311Hamamatsu 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
HAS. Guide ALD-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer colorectal Adénocarcinome. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs
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.
PubMed 19326450Ishizuka 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.
PubMed 22260827Jarnagin 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.
PubMed 11333094Morita 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.
PubMed 22200990O2View. 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. doi: 10.1097/01.sla.0000160703.75808.7d.
PubMed 15849507
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01738217
- Acronym / sponsor ID
- HEPATOFLUO / HEPATOFLUO
- Conditions
- Liver Neoplasms
- Keywords
- Intra-operative imaging, NIR Fluorescence, Liver surgery, Tumoral margins
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluobeam | Experimental | Procedure: Fluobeam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluobeam | Procedure or surgery | Fluobeam |
Primary outcome
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
14 secondary outcomes
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
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
Second step: assess the rate of modifications of the surgical plan.
Time frame: During surgery on day 0
Second step: assess the quality of the resection margins.
Time frame: After the surgery on day 0
Second step: assess the depth limit of detection of the fluorescence.
Time frame: After the pathology analysis on day 0
Second step: Quantify the fluorescence.
Time frame: After the surgery, on day 0
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
Third step: quantify the fluorescence.
Time frame: After the surgery on day 0
Third step: assess the ability to administer two doses of ICG in the same patient
Time frame: On day 0
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Background: PubMed 19844652Aoki 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.
- Background: PubMed 18543027Aoki 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.
- BackgroundBarbare JC. Quantification de la fonction hépatique: Pourquoi et comment? John Libbey Eurotext. HEPATO-GASTRO.5(6):423-431,1998.
- Background: PubMed 9809562Billingsley 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.
- Background: PubMed 19301311Gotoh 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.
- 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
- BackgroundHAS. Guide ALD-Tumeur maligne, affection maligne du tissu lymphatique ou hématopoïétique-Cancer colorectal Adénocarcinome. http://www.e-cancer.fr/soins/recommandations/cancers-digestifs
- Background: PubMed 19326450Ishizawa 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.
- Background: PubMed 22260827Ishizuka 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.
- Background: PubMed 11333094Jarnagin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Peyrat principal investigator
Centre Léon Bérard, LYON, FRANCE.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluobeam in people with Liver Neoplasms, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First step: assess the feasibility and the acceptability of Fluobeam (time frame: During surgery on day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738217, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.