E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
|
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
|
E.2.2 | Secondary objectives of the trial |
- 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)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as the last visit of the last patient. This time point is reached when the patient has undergone Primovist-enhanced imaging. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |