Contrast-enhanced Imaging of the Abdomen: Gadovist® vs. Dotarem® – Intraindividual comparison of 0.1mmol/kg bw gadoterate meglumine with 0.1mmol/kg bw gadobutrol for dynamic abdominal imaging in patients with suspected focal liver or renal lesions - CIA-GaDo

• Conditions: patients with suspected focal liver or renal lesions; MedDRA version: 9.1Level: LLTClassification code 10039533Term: Scan NOS abdomen abnormal

• Registration Number: EUCTR2009-009426-81-DE
• Lead Sponsor: niversity Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-02
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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