Patients with liver cirrhosis and diagnosis of hepatocellular carcinoma based on noninvasive HCC diagnostic (EASL) criteria MedDRA version: 18.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 100000004871 MedDRA version: 18.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Primovist
Product Name: Primovist
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOXETIC ACID
CAS Number: 135326-11-3
Concentration unit: mmol/ml millimole(s)/millilitr
Sponsors
Charite
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients at least 18 years of age 2. Patient has personally signed and dated the written informed consent form 3. Willing to undergo all study procedures 4. Liver cirrhosis Child score A or higher 5. Diagnosis of hepatocellular carcinoma based on noninvasive HCC diagnostic (EASL) criteria 6. Clinical indication for liver MRI 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Female patients who are in (or suspected of) pregnancy or nursery. In women of child bearing potential a pregnancy test must be performed before inclusion in this study. 2. Patients with impaired renal function (GFR < 30 ml/min/1.73m², MDRD formula, creatinine value = 4 weeks) 3. Patients with a known allergy and/or hypersensitivity to MR contrast agents or history of anaphylactoid or anaphylactic reaction to any contrast media, or being at high risk for hypersensitivity reactions. The risk of hypersensitivity is higher in patients with history of bronchial asthma and history of allergic disorders; hypersensitivity reactions can be more intense in patients on beta-blockers 4. Patients with contraindications to MR imaging (severe claustrophobia, non-compatible implants like cardiac pacemaker, ferromagnetic clips, implanted infusion pumps, implanted electrical nerve stimulation devices, cochlear implant, any metallic foreign bodies) 5. Patients with known allergy and/or hypersensitivity or any contraindication to Dotarem and/or Primovist and/or patients assumed to be at increased risk for adverse events after application of MR contrast agents (e.g., seizure, increase in creatinine values) 6. Patients with any physical or mental status interfering with the informed consent procedure including self-signed informed consent 7. Being unstable or requiring emergency treatment 8. Patients requiring or scheduled for liver transplantation 9. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 10. with close affiliation with the investigational site; e.g. a close relative of the investigator 11. Participating in another diagnostic clinical trial 12. Having previously entered this study. 13. Being hospitalized following an official order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: (1) Signal-to-noise (SNR) and contrast-to-noise (CNR) values (calculated based on signal intensity measurements); (2) Quantitative assessment of time-to-peak, upslope, time to 100% enhancement, percentage signal increase [(SIpost – Sipre)/SIpre] *100, and washout; (3) Qualitative assessment: Lesion conspicuity (margin, intensity, homogeneity) ;Primary end point(s): Maximum enhancement (calculated as: SI post-contrast [lesion] - SI pre-contrast [lesion]).;Timepoint(s) of evaluation of this end point: independent image analysis after conclusion of the clinical part of the study;Main Objective: To compare the peak maximum enhancement between both contrast agents in the lesion with reference to normal tissue (peak enhancement = SI post-contrast (lesion) - SI pre-contrast (lesion)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Time-to-peak (2) Upslope (3) Time to 100% enhancement (4) percentage increase in enhancement (SIpost – SIpre)/SIpre *100 (5) Washout (6) qualitative assessment of lesion conspicuity (Margin, Intensity, Homogeneity );Timepoint(s) of evaluation of this end point: independent image analysis after conclusion of the clinical part of the study | — |
Countries
Germany
Contacts
Public ContactRadiologist, PI
Charité
Outcome results
None listed