E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All benign and malignant focal liver lesions e.g. colorectal liver metastases, HCC, haemangioma, adenoma, cysts, FNH. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024658 |
E.1.2 | Term | Liver carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027479 |
E.1.2 | Term | Metastatic liver carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019827 |
E.1.2 | Term | Hepatocellular adenoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049010 |
E.1.2 | Term | Carcinoma hepatocellular |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019396 |
E.1.2 | Term | Hemangioma of liver |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048834 |
E.1.2 | Term | Polycystic liver disease |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052285 |
E.1.2 | Term | Focal nodular hyperplasia |
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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 determine the diagnostic value of MR-Primovist and Respiratory Triggered DWI MRI for the detection and characterization of focal liver lesions . |
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E.2.2 | Secondary objectives of the trial |
To determine the agreement for lesion detection and characterization between MR-Gadovist and MR-Primovist on per lesion basis To assess the effect of MR-Primovist findings (lesion type, size, localisation) on surgical management (resection procedure) of patients with resectable disease
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age > 18 years - suspicion of focal liver lesions, both benign and/or malignant: Benign: - Haemangioma - Focal Nodular Hyperplasia - Adenoma - Cyst - Cystadenoma Malignant: - Metastasis - Hepatocellular Carcinoma (HCC) - Cholangiocarcinoma
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E.4 | Principal exclusion criteria |
- primary clinical query on the liver MRI chart: liver cirrhosis, hepatitis, steatosis, or liver abscess, or any other liver disease not defined as focal disease. - previous liver surgery - a pacemaker - severe renal disease (creatinin clearance <30ml/min or haemodialysis is necessary) - administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist. - claustrophobia - hypersensitivity to the active substances or any of the recipients of Gd-EOB-DTPA contrast: - previous reaction to contrast media - history of bronchial asthma - history of allergic disorders causing anaphylactic shock - caution should be exercised in patients with clinically severe cardiovascular disease. Myocardial infarction, uncontrolled hypertension, instable angina pectoris, congestive heart failure, uncontrolled arrhythmia’s requiring medication - pregnancy or lactating women (in case of uncertainty, a pregnancy test will be performed) - treatment with rifampicin (inhibitor of Gd-EOB-DTPA uptake)
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E.5 End points |
E.5.1 | Primary end point(s) |
Main study parameter/endpoint: - Negative predictive value and positive predictive value for the detection and characterization of focal liver lesions on a per patient basis.
Secondary study parameters/endpoints: - Secondary parameters: Accuracy and agreement between MR-Gadovist and MR-Primovist for lesion detection and characterization on a per lesion basis - Change in surgical strategy |
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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) | 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 | No |
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 | Information not present in EudraCT |
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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End of the trial: after the inclusion of all 230 patients who received all the diagnostic techniques as proposed in the protocol. |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |