Patients of both genders are eligible for this study in case they present with suspicion of HCC after Gadovist® -enhanced MRI. MedDRA version: 12.0 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable MedDRA version: 12.0 Level: LLT Classification code 10036707 Term: Primary liver cancer recurrent MedDRA version: 12.0 Level: LLT Classification code 10036708 Term: Primary liver cancer resectable
Conditions
Interventions
Trade Name: Primovist
Product Code: V08 C A10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOXETIC ACID
CAS Number: 135326113
Concentration unit: mmol/kg millimole(s)/kilogram
Co
Sponsors
Medizinische Fakultät Mannheim, Ruprecht-Karls-Universität Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to prove the non-inferiority of Primovist® vs. Gadovist® for detection of HCC using a truth panel assessment as the SOR;Secondary Objective: • 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®) ;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) | — |
Countries
Germany
Outcome results
None listed