patients with suspected focal liver or renal lesions MedDRA version: 9.1 Level: LLT Classification code 10039533 Term: Scan NOS abdomen abnormal
Conditions
Interventions
Trade Name: Gadovist 1.0 mmol/ml, Injektionslösung
Product Code: V08CA09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOBUTROL
CAS Number: 138071-82-6
Concentration unit: mmol/ml
Sponsors
University Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjected to MR imaging of the liver or of the kidneys for clinical reasons 2. willing to undergo two MR-exams within 14 days 3. Age: 18 – 85 years 4. Provided written 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. Glomerular filtration rate (GFR) less than 50ml/min/1.73m2, calculated with the MDRD formula. The values must not be older than 1 week before the examination. 2. If female, pregnant or breast-feeding 3. MR contraindications, e.g. pacemaker, magnetic clips or several claustrophobia 4. Intervention or change in therapy between the two MR examinations 5. Known allergy to any ingredient of Gadovist or Dotarem 6. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents 7. Having received another investigational drug within the last 30 days prior to inclusion into this study 8. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent 9. Close affiliation with the investigational site; e.g. a close relative of the investigator 10. Having been previously enrolled in this study 11. Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show in an intra-individual comparison the superiority of Gadovist®-enhanced images over Dotarem®-enhanced images in patients with suspected or known lesions of the liver or the kidneys by two blinded radiologists ;Secondary Objective: The secondary objectives comprise the determination of the technical parameters SNR and CNR: • Aorta during the first pass (20s post injection) • Aorta during the portalvenous phase (40s post injection) • Portal vein during the portalvenous phase (40s post injection) • Liver during the portalvenous phase (40s post injection) • Kidney during the portalvenous phase (40s post injection) • Pancreas during the portalvenous phase (40s post injection) • Liver, kidney, pancreas during the delayed phase (80s post injection) • Largest liver mass (20s, 40s and 80s post injection) • Largest renal mass (20s, 40s and 80s post injection) ;Primary end point(s): Technical (quantitative) assessment of the difference of • SNR • CNR - image quality | — |
Countries
Germany
Outcome results
None listed