Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

Phase 3

Terminated

• Conditions: Renal Disease
• Interventions: Other: Time of Flight; Drug: Dotarem

• Registration Number: NCT00980681
• Lead Sponsor: Guerbet

Brief Summary

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed Description

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2015-07-24
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Male or female, aged more than 18 years
• Strongly suspected of having renal arterial disease
• Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria

• Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
• Contraindication to MRI
• Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time Of Flight	Time of Flight	Each subject will undergo a TOF Magnetic Resonance Angiography
Dotarem	Dotarem	Each subject will receive one injection of Dotarem 0.2ml/kg.

Primary Outcome Measures

Name	Time	Method
Percent of Non Assessable Renal Artery Segments	1 to 7 days	For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

Trial Locations

Locations (1)

Guerbet LLC; 🇺🇸 Bloomington, Indiana, United States