Assessment of focal liver lesions in fluoroscopic MR using Primovist and fast dynamic imaging sequences for interventional purposes - Liver lesions in fluoroscopic MR

• Conditions: The purpose of this study is to evaluate the potential of a better demarcation of liver lesions after injection of the hepatocyte specific contrast agent Gadoxetic acid (Primovist) with fast dynamic imaging (fluoroscopic sequences) in comparison to non-enhanced MR imaging to allow a better targeting of liver lesions for biopsies or tumor ablation.

• Registration Number: EUCTR2008-004991-28-DE
• Lead Sponsor: Medical Faculty Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1.age: between 18 and 85 years
2.patients with focal liver lesions between 0.5 and 5 cm (reported in previous CT or MR investigations) who are scheduled for biopsy for clinical reasons.
3.if female, postmenopausal or surgically sterilized
4.willing and able to undergo all study procedures
5.having voluntarily provided written and fully informed consent

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

1.coagulation disorder (TPZ < 70%, PTT > 35 sec. , platelets < 100000/ml)
2.history of severe allergic reaction to MR contrast media or to Primovist (or on of its ingredients)
3.severe and moderate renal failure (GFR <60 mL as calculated according to the MDRD or Cockroft-Gault formula)
4.women who are pregnant, lactating or who are of childbearing potential
5.patients being clinically unstable
6.uncooperative, in the investigator’s opinion
7.any contraindication to MR examinations
8.having been previously enrolled in this study
9.participating in another clinical trial

Study & Design

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