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.
Conditions
Interventions
Trade Name: Primovist
Product Name: Primovist
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadoxetic acid disodium
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration
Sponsors
Medical Faculty Magdeburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. coagulation disorder (TPZ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, whether the contrast of focal liver lesions in Primovist enhanced fast dynamic imaging (fluoroscopic sequences, T1FFE) is not inferior compared to standard diagnostic imaging using T1 weighted 3D high resolution sequences (THRIVE).;Secondary Objective: - To investigate the differences of SNR (signal to noise ratio) and CNR (contrast to noise ratio) of contrast enhanced T1FFE and THRIVE sequences - To investigate the differences of the SNR and CNR of contrast enhanced T1FFE and non-enhanced dynamic sequences (ssTSE, bTFE, T1FFE) ;Primary end point(s): Comparison of the image quality on the basis of a 10 point scale between the contrast enhanced T1W-FFE sequence and the contrast enhanced standard sequence THRIVE. | — |
Countries
Germany
Outcome results
None listed