E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatocellular carcinoma, hepatic adenoma, intrahepatic cholangiocarcinoma, colorectal liver metastases |
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E.1.1.1 | Medical condition in easily understood language |
Primary malignant liver tumor Non-malignant liver tumor Malignant secondary liver tumor |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to investigate the feasibility of using intra-arterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate the dosage which provides sufficient contrast index of ICG in the liver segment compared to normal liver tissue. 2. To investigate the optimal timing of administration of the ICG-mixture without being washed out of a liver segment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Scheduled for open or laparoscopic anatomical liver resection; 2. Patients aged over 18 years old; 3. Has the ability to communicate well with the investigator in Dutch or English and willing to comply with the study design; 4. Signed informed consent prior to any study-mandated procedure.
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E.4 | Principal exclusion criteria |
1. Previous major abdominal surgery 2. Known allergy or history of adverse reaction to ICG, lipiodol, gel foam, iodine or iodine contrast agents; 3. Child Pugh B or C 4. Portal hypertension or portal vein thrombosis 5. eGFR: <30; in case of eGFR 30-59 metformin should be stopped >48 hours prior to Lipiodol administration and continued >48 hours after Lipiodol administration 6. Hyperthyroidism or a benign thyroid tumor; 7. Pregnant or breastfeeding women; 8. Scheduled for palliative surgery or terminally ill 9. Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history and physical examination); 10. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; 11. Emergency surgery.
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E.5 End points |
E.5.1 | Primary end point(s) |
The feasibility of using intra-arterial ICG and embolization preoperatively to allow for liver segment visualization during anatomical liver resection. Visibility will be measured using a contrast ratio between normal liver parenchyma and ICG colored liver parenchyma. A signal-to-background ratio of 1.6 provides sufficient contrast for an anatomical resection and will therefore be used as endpoint. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed. |
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E.5.2 | Secondary end point(s) |
1. Time ideal window between intervention radiology and operation will be increased after every two successful liver segment visualizations (contrast ratio of ≥1.6). The endpoint for this parameter is 24 hours, and will be confirmed in 4 consecutive patients. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 12 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |