E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients of both genders are eligible for this study in case they present with suspicion of HCC after Gadovist® -enhanced MRI. |
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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 | 10036706 |
E.1.2 | Term | Primary liver cancer non-resectable |
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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 | 10036707 |
E.1.2 | Term | Primary liver cancer recurrent |
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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 | 10036708 |
E.1.2 | Term | Primary liver cancer resectable |
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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 prove the non-inferiority of Primovist® vs. Gadovist® for detection of HCC using a truth panel assessment as the SOR |
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E.2.2 | Secondary objectives of the trial |
• to assess the total number of liver lesions (Gadovist® vs. Primovist®) • to assess the confidence in diagnosis (Gadovist® vs. Primovist®) • to assess SNR and CNR of liver lesions (Gadovist® vs. Primovist®)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Liver lesion, suspicion of hepatocellular carcinoma 2. Having received Gadovist®-enhanced MRI of the liver for clinical reasons 3. Age: 18-80 years 4. Willing to comply with the study procedures 5. Patients who have given their fully informed and written consent voluntarily
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E.4 | Principal exclusion criteria |
1. If female, of childbearing potential 2. GFR <50 mL/min/1.73m² (MDRD or Cockroft-Gault formula), values ≤4 weeks 3. Not being able to remain lying down for at least 45-60 min (e.g., patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain) 4. Known allergy to any ingredient of Primovist® 5. Any contraindication for Primovist® (according to SmPC) 6. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents 7. Being clinically unstable 8. Having any contraindication to MRI examination (e.g., pacemaker, recent wound clips, and severe claustrophobia). 9. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent 10. Close affiliation with the investigational site; e.g. a close relative of the investigator 11. Having been previously enrolled in this study 12. Participating in another clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity for detection of HCC taking a truth panel assessment as the standard of reference (on the basis of liver segments) |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |