Comparison of 2 contrast agents for Magnetic Resonance Imaging in patients with liver cancer

Phase 1

• Conditions: Patients with liver cirrhosis and diagnosis of hepatocellular carcinoma based on noninvasive HCC diagnostic (EASL) criteria; MedDRA version: 18.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; MedDRA version: 18.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-002409-75-DE
• Lead Sponsor: Charite

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-23
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified