Liver CancerI-FIGSNCT05616039
I-FIGS Feasibility Study
A study testing Standard Liver Surgery and Indocyanine Fluorescent Image Guided Surgery (I-FIGS) in people with Liver Cancer and Hepatocellular Carcinoma, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Background: Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma, Liver Metastasis Colon Cancer
- What is being tested?
- Standard Liver Surgery and Indocyanine Fluorescent Image Guided Surgery (I-FIGS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Nov 2022to 30 May 2024
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients (>16 years) requiring elective open/laparoscopic liver resection/s for liver metastases, primary hepatocellular and peripheral cholangiocarcinoma will be included in the study.
Who cannot join
- Patients allergic to iodine/contrast or shellfish
- Patients unable to consent to the study
- Patients with suspected liver adenomas and biliary cystadenomas
- Patients with suspected hilar cholangiocarcinoma
- Patients requiring emergency liver surgery
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
About this study
Official title: A Feasibility Randomised Controlled Study to Test the Use of Indocyanine Green Fluorescence Image-Guidance in Liver Surgery Compared to Standard Liver Surgery Alone in Reducing Microscopic Positive Tumour Resection Rate
Background:
Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer (2). Various techniques are used by the surgeons to identify the cancer tissue from the normal liver during the surgery so that it can be removed completely. These include examining with the naked eye, having a feel of the tumour, and performing an ultrasound scan. Even with these techniques it is difficult to identify the exact extent of the cancer. Also, the interpretation of the ultrasound scan can be subjective (3). A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue.
Read more
Indocyanine green (ICG) is a dye which when given through the veins, is taken up and retained by cancer cells in the liver and they appear as fluorescent areas as compared to normal liver which appears dark. This principle can be used to identify the cancerous tissue accurately during the surgery and remove it completely (Indocyanine green Fluorescence Image-Guided Surgery: I-FIGS). It can also potentially detect additional tumours which were not identified before the surgery or during the surgery with standard techniques (4,5). However, there is a lack of good quality evidence on the usefulness of I-FIGS in liver surgery, so this needs to be tested in a large group of patients having liver surgery before any recommendations can be made.
Research Aim:
This initial study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. Investigators will assess if patients are willing to take part in the study and whether they can gather relevant clinical outcome data from them all. Investigators will also gather patients' views about this novel technique and participating in the study.
Design and methods:
This study will involve 40 patients having planned liver surgery for liver tumour/s recruited from University Hospitals, Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard liver surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery (0.03-0.05mg/kg dose) on the day of surgery. The surgical planning will be carried out as per the standard approach using the naked eye and intra-operative ultrasound examination. Once this is all recorded, ICG cameras will be switched on, and the additional findings and change to surgical plan will be noted. Focus groups will explore participants experiences of being in the study. This will inform the design of the future larger trial.
Patient public involvement:
Investigators have involved patients who have had or are having liver surgery in the development of the study. Their views on the technique, trial procedures and outcome measures have been incorporated. They will continue to be involved and advise on the study.
Dissemination:
Results will be available via research journals and conferences.
- Being tested
- Standard Liver Surgery, Indocyanine Fluorescent Image Guided Surgery (I-FIGS)
- Keywords
- Indocyanine green, Fluorescence Image Guided Surgery
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Liver SurgeryProcedure or surgery
Standard liver surgery using naked eye examination +/- palpation and intra-operative ultrasound scan (IOUS) examination to identify and remove liver tumours
Indocyanine Fluorescent Image Guided Surgery (I-FIGS)Diagnostic test
Use of I-FIGS in accurate identification of tumours and their margins
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard liver surgery) | Active comparator | In this group, tumour/s, resection margin identification, and the type and number of liver resections will be based on naked eye examination, palpation, and intraoperative ultrasound. All the intra-operative findings will be recorded on a pre-designed proforma, and these details include the type of surgical approach (open, laparoscopic, and hand-assisted), if it is an open operation the type of incision, the location, number and size of tumour/s, relationship of the tumour/s to inflow and outflow of the liver, duration of surgery, and estimated blood loss. Post-operatively histology of the resected specimen including resection margin status will be recorded. Receives: Procedure: Standard Liver Surgery |
| Intervention Group (I-FIGS) | Experimental | Patients will receive intravenous indocyanine green(ICG) injection (0.03-0.05mg/kg) 2-4 hours before surgery. ICG comes in crystal form in 25mg dose. It will be diluted with 25ml of water, and the required dose as per the weight of the patient will be prepared freshly and given at least 2-4 hours before surgery. The surgical planning will be carried out as per the standard approach using the naked eye and IOUS. As for standard surgery, all intra-operative findings will be recorded on the proforma that contains the details that need to be collected. Once this is all recorded, ICG cameras will be switched on, and the additional findings (additional lesions detected, additional resections carried out) and change to surgical plan (change to the line of parenchymal transection) will be noted. Post-operatively histology of the resected specimen including resection margin status will be recorded. Receives: Procedure: Standard Liver Surgery; Diagnostic Test: Indocyanine Fluorescent Image Guided Surgery (I-FIGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes
- screening and recruitment rate
- retention rate
- adherence rates to study methods and procedures (consent, randomisation, intervention, data collection)
Measured: 10 weeks (from the day of recruitment till the histopathology report is available)
Clinical outcomes- Microscopic positive resection margin rate
Number of patients with microscopic positive resection margins as compared to total number of patients, measured as percentage.
Microscopic positive resection margin is defined as presence of tumour cells < 1 mm from the resection margin.
Measured: From the day of surgery till the histopathology report is available (approximately 6 weeks)
Secondary outcomes (4)
Number of additional tumours detected
Number of additional tumours detected by I-FIGS compared to Intra-operative ultrasound scan (IOUS) will be noted for each patient. A median value and range will be calculated for both the groups.
Measured: On the day of surgery
Duration of surgery
This will be measured in minutes on the day of surgery. This will include the time from the time incision is taken (knife to skin) till the patient is extubated. A median value and range will be calculated for both the groups.
Measured: On the day of surgery
Post-operative length of stay
This will be measured in number of days for each patient. A median value and range will be calculated for both the groups.
Measured: From the day of surgery till the day of discharge (approximately 10 days)
Complications
If case of any complications, these will be graded as per the Clavien-Dindo grading system.
The unit of measure will be the Clavien-Dindo grade.
Measured: From the day of recruitment till the day of discharge (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start23 Nov 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somaiah Aroori, Study director, University Hospital Plymouth NHS TrustRahi Karmarkar, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616039
- Sponsor's protocol ID
- 317378
- Acronym
- I-FIGS
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2022
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we don not plan to share the raw individual patient data. However, the results of the study will be made available via research journals and conferences.
Publications
Mise Y, Sakamoto Y, Ishizawa T, Kaneko J, Aoki T, Hasegawa K, Sugawara Y, Kokudo N. A worldwide survey of the current daily practice in liver surgery. Liver Cancer. 2013 Jan;2(1):55-66. doi: 10.1159/000346225.
PubMed 24159597Chan AWH, Zhong J, Berhane S, Toyoda H, Cucchetti A, Shi K, Tada T, Chong CCN, Xiang BD, Li LQ, Lai PBS, Mazzaferro V, Garcia-Finana M, Kudo M, Kumada T, Roayaie S, Johnson PJ. Development of pre and post-operative models to predict early recurrence of hepatocellular carcinoma after surgical resection. J Hepatol. 2018 Dec;69(6):1284-1293. doi: 10.1016/j.jhep.2018.08.027. Epub 2018 Sep 18.
PubMed 30236834Joo I. The role of intraoperative ultrasonography in the diagnosis and management of focal hepatic lesions. Ultrasonography. 2015 Oct;34(4):246-57. doi: 10.14366/usg.15014. Epub 2015 Apr 6.
PubMed 25971896Faybik P, Hetz H. Plasma disappearance rate of indocyanine green in liver dysfunction. Transplant Proc. 2006 Apr;38(3):801-2. doi: 10.1016/j.transproceed.2006.01.049.
PubMed 16647475Ishizawa T, Saiura A, Kokudo N. Clinical application of indocyanine green-fluorescence imaging during hepatectomy. Hepatobiliary Surg Nutr. 2016 Aug;5(4):322-8. doi: 10.21037/hbsn.2015.10.01.
PubMed 27500144
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Study to Test the Use of Indocyanine Green Fluorescence Image-Guidance in Liver Surgery Compared to Standard Liver Surgery Alone in Reducing Microscopic Positive Tumour Resection Rate
- ClinicalTrials.gov ID
- NCT05616039
- Acronym / sponsor ID
- I-FIGS / 317378
- Keywords
- Indocyanine green, Fluorescence Image Guided Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- 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.
Background:
Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer (2). Various techniques are used by the surgeons to identify the cancer tissue from the normal liver during the surgery so that it can be removed completely. These include examining with the naked eye, having a feel of the tumour, and performing an ultrasound scan. Even with these techniques it is difficult to identify the exact extent of the cancer. Also, the interpretation of the ultrasound scan can be subjective (3). A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue.
Indocyanine green (ICG) is a dye which when given through the veins, is taken up and retained by cancer cells in the liver and they appear as fluorescent areas as compared to normal liver which appears dark. This principle can be used to identify the cancerous tissue accurately during the surgery and remove it completely (Indocyanine green Fluorescence Image-Guided Surgery: I-FIGS). It can also potentially detect additional tumours which were not identified before the surgery or during the surgery with standard techniques (4,5). However, there is a lack of good quality evidence on the usefulness of I-FIGS in liver surgery, so this needs to be tested in a large group of patients having liver surgery before any recommendations can be made.
Research Aim:
This initial study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. Investigators will assess if patients are willing to take part in the study and whether they can gather relevant clinical outcome data from them all. Investigators will also gather patients' views about this novel technique and participating in the study.
Design and methods:
This study will involve 40 patients having planned liver surgery for liver tumour/s recruited from University Hospitals, Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard liver surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery (0.03-0.05mg/kg dose) on the day of surgery. The surgical planning will be carried out as per the standard approach using the naked eye and intra-operative ultrasound examination. Once this is all recorded, ICG cameras will be switched on, and the additional findings and change to surgical plan will be noted. Focus groups will explore participants experiences of being in the study. This will inform the design of the future larger trial.
Patient public involvement:
Investigators have involved patients who have had or are having liver surgery in the development of the study. Their views on the technique, trial procedures and outcome measures have been incorporated. They will continue to be involved and advise on the study.
Dissemination:
Results will be available via research journals and conferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard liver surgery) | Active comparator | Procedure: Standard Liver SurgeryIn this group, tumour/s, resection margin identification, and the type and number of liver resections will be based on naked eye examination, palpation, and intraoperative ultrasound. All the intra-operative findings will be recorded on a pre-designed proforma, and these details include the type of surgical approach (open, laparoscopic, and hand-assisted), if it is an open operation the type of incision, the location, number and size of tumour/s, relationship of the tumour/s to inflow and outflow of the liver, duration of surgery, and estimated blood loss. Post-operatively histology of the resected specimen including resection margin status will be recorded. |
| Intervention Group (I-FIGS) | Experimental | Procedure: Standard Liver Surgery, Diagnostic Test: Indocyanine Fluorescent Image Guided Surgery (I-FIGS)Patients will receive intravenous indocyanine green(ICG) injection (0.03-0.05mg/kg) 2-4 hours before surgery. ICG comes in crystal form in 25mg dose. It will be diluted with 25ml of water, and the required dose as per the weight of the patient will be prepared freshly and given at least 2-4 hours before surgery. The surgical planning will be carried out as per the standard approach using the naked eye and IOUS. As for standard surgery, all intra-operative findings will be recorded on the proforma that contains the details that need to be collected. Once this is all recorded, ICG cameras will be switched on, and the additional findings (additional lesions detected, additional resections carried out) and change to surgical plan (change to the line of parenchymal transection) will be noted. Post-operatively histology of the resected specimen including resection margin status will be recorded. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (>16 years) requiring elective open/laparoscopic liver resection/s for liver metastases, primary hepatocellular and peripheral cholangiocarcinoma will be included in the study.
Key exclusion criteria (6 listed)
- Patients allergic to iodine/contrast or shellfish
- Patients unable to consent to the study
- Patients with suspected liver adenomas and biliary cystadenomas
- Patients with suspected hilar cholangiocarcinoma
- Patients requiring emergency liver surgery
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 |
|---|---|---|
| Standard Liver SurgeryStandard liver surgery using naked eye examination +/- palpation and intra-operative ultrasound scan (IOUS) examination to identify and remove liver tumours | Procedure or surgery | Control Group (Standard liver surgery), Intervention Group (I-FIGS) |
| Indocyanine Fluorescent Image Guided Surgery (I-FIGS)Use of I-FIGS in accurate identification of tumours and their margins | Diagnostic test | Intervention Group (I-FIGS) |
Primary outcome
Feasibility outcomes
Time frame: 10 weeks (from the day of recruitment till the histopathology report is available)
* screening and recruitment rate * retention rate * adherence rates to study methods and procedures (consent, randomisation, intervention, data collection)
Clinical outcomes- Microscopic positive resection margin rate
Time frame: From the day of surgery till the histopathology report is available (approximately 6 weeks)
Number of patients with microscopic positive resection margins as compared to total number of patients, measured as percentage. Microscopic positive resection margin is defined as presence of tumour cells < 1 mm from the resection margin.
4 secondary outcomes
Number of additional tumours detected
Time frame: On the day of surgery
Duration of surgery
Time frame: On the day of surgery
Post-operative length of stay
Time frame: From the day of surgery till the day of discharge (approximately 10 days)
Complications
Time frame: From the day of recruitment till the day of discharge (approximately 4 weeks)
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 1 Aug 2025.
- Background: PubMed 24159597Mise Y, Sakamoto Y, Ishizawa T, Kaneko J, Aoki T, Hasegawa K, Sugawara Y, Kokudo N. A worldwide survey of the current daily practice in liver surgery. Liver Cancer. 2013 Jan;2(1):55-66. doi: 10.1159/000346225.
- Background: PubMed 30236834Chan AWH, Zhong J, Berhane S, Toyoda H, Cucchetti A, Shi K, Tada T, Chong CCN, Xiang BD, Li LQ, Lai PBS, Mazzaferro V, Garcia-Finana M, Kudo M, Kumada T, Roayaie S, Johnson PJ. Development of pre and post-operative models to predict early recurrence of hepatocellular carcinoma after surgical resection. J Hepatol. 2018 Dec;69(6):1284-1293. doi: 10.1016/j.jhep.2018.08.027. Epub 2018 Sep 18.
- Background: PubMed 25971896Joo I. The role of intraoperative ultrasonography in the diagnosis and management of focal hepatic lesions. Ultrasonography. 2015 Oct;34(4):246-57. doi: 10.14366/usg.15014. Epub 2015 Apr 6.
- Background: PubMed 16647475Faybik P, Hetz H. Plasma disappearance rate of indocyanine green in liver dysfunction. Transplant Proc. 2006 Apr;38(3):801-2. doi: 10.1016/j.transproceed.2006.01.049.
- Background: PubMed 27500144Ishizawa T, Saiura A, Kokudo N. Clinical application of indocyanine green-fluorescence imaging during hepatectomy. Hepatobiliary Surg Nutr. 2016 Aug;5(4):322-8. doi: 10.21037/hbsn.2015.10.01.
- Individual participant dataSharing planned: No. No, we don not plan to share the raw individual patient data. However, the results of the study will be made available via research journals and conferences.
Related trials for Liver Cancer
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
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.
Somaiah Aroori study director
University Hospital Plymouth NHS Trust
Rahi Karmarkar principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Liver Surgery and Indocyanine Fluorescent Image Guided Surgery (I-FIGS) in people with Liver Cancer and Hepatocellular Carcinoma, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 6 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 1 Aug 2025. 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 United Kingdom. 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.
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?
Feasibility outcomes (time frame: 10 weeks (from the day of recruitment till the histopathology report is available)). The study lists 2 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 NCT05616039, which also lists 5 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 1 Aug 2025.