E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatocellular adenoma |
Hepatocellulair adenomata |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with liver disease |
Patiënten met een leveraandoening. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To analyse if dual energy CT can be used for analysis of Primovist uptake in liver lesions like FNHs and adenomas.
Primary objective: Difference in density of the liver compared to virtual non contrast CT |
Om te analyseren of de Dual Energy CT scanner gebruikt kan worden voor de analyse van de opname van Primovist in leverlaesies zoals FNH's en adenomen.
Primair doel: Verschil in dichtheid van de lever in vergelijking met virtuele non-contrast CT |
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E.2.2 | Secondary objectives of the trial |
Measurable difference in density between liver and hepatocellular adenoma and FNHs |
Meetbaar verschil in dichtheid tussen lever en hepatocellulair adenoom en FNH's |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- MRI with Primovist before CT scan
- Diagnosis of minimally one FNH (5 patients) and one HCA (5 patients)
- Lesion must be at least 3 cm
- Age of 18 years or older |
- MRI met primovist voorafgaand aan de CT scan
- Diagnose van minimaal één FNH (5 patiënten) en minimaal één HCA (5 patiënten)
- Laesie moet minimaal 3 cm zijn
- Leeftijd van 18 jaar of ouder |
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E.4 | Principal exclusion criteria |
- No contraindication for CT (pregnancy) |
- Geen contra-indicatie voor de CT scanner (zwangerschap) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Significant difference in density of the liver compared to the virtual non-contrast images of the liver. This will be measured quantitatively, based on a minimal enhancement of 20 Hounsfield Units.
Significant difference in density of the FNHs/adenomas compared to the surrounding liver, both quantitatively as qualitatively. Quantitative difference has to be minimally 20 Hounsfield Units. Qualitative evaluation will be performed by 2 experienced radiologists, without knowing location and final diagnosis from MRI or each others interpretation. The evaluation by the radiologists will be performed on a standard workstation with application of Siemens (Syngovia). |
Significant verschil in dichtheid van de lever in vergelijking met de virtuele niet-contrastbeelden van de lever. Dit wordt kwantitatief gemeten gebaseerd op een minimale verbetering van 20 Hounsfield-eenheden.
Aanzienlijk verschil in dichtheid van de FNH's / adenomen in vergelijking met de omringende lever, zowel kwantitatief als kwalitatief. Kwantitatief verschil moet minimaal 20 Hounsfield-eenheden zijn. Kwalitatieve evaluatie zal worden uitgevoerd door 2 ervaren radiologen, zonder de locatie en uiteindelijke diagnose te kennen van MRI of elkaars interpretatie. De evaluatie door de radiologen zal worden uitgevoerd op een standaardwerkstation met toepassing van Siemens (Syngovia) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the last included patient scan is performed. |
Nadat de 10 patiënten zijn geïncludeerd. |
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E.5.2 | Secondary end point(s) |
Minimal dose needed for accurate differentiation based on difference of minimally 20 Hounsfield Units. |
Minimale dosis nodig voor nauwkeurige differentiatie op basis van verschil van minimaal 20 Hounsfield-eenheden. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the last included patient scan is performed. |
Nadat de 10 patiënten zijn geïncludeerd. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.3 |
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 | |
E.8.9.1 | In the Member State concerned days | |