EUCTR2013-002409-75-DEActive, not recruitingPhase 1
Intra-individual, comparison of the MRI contrast agents gadoxetic acid (Primovist®) versus gadoterate meglumine (Dotarem®) in liver MRI of patients with HCC and underlying cirrhosis
Charite0 sites30 target enrollmentStarted: August 23, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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