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

This study has been terminated.

(lack of recruitment.)

Sponsor:

Information provided by (Responsible Party):

Guerbet

ClinicalTrials.gov Identifier:

NCT00845702

First received: February 16, 2009

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Renal Artery Stenosis	Drug: Gadoterate meglumine (Dotarem) Other: Time of Flight Magnetic Resonance Angiography	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Resource links provided by NLM:

Drug Information available for: Meglumine Gadoterate meglumine

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:

Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ] [ Designated as safety issue: No ]
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared


Enrollment:	33
Study Start Date:	April 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dotarem Each subject will receive one injection of Dotarem 0.2 ml/kg.	Drug: Gadoterate meglumine (Dotarem) Each subject will receive one injection of Dotarem 0.2 ml/kg
Time Of Flight Magnetic Resonance Angiography Each subject undergo a TOF MRA	Other: Time of Flight Magnetic Resonance Angiography Each subject will undergo a TOF MRA

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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,

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845702

Locations


United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403

Sponsors and Collaborators

Guerbet

More Information

No publications provided


Responsible Party:	Guerbet
ClinicalTrials.gov Identifier:	NCT00845702 History of Changes
Other Study ID Numbers:	DGD-44-046
Study First Received:	February 16, 2009
Results First Received:	September 22, 2011
Last Updated:	April 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Guerbet:


Renal artery stenosis Contrast agent MRA

Additional relevant MeSH terms:


Gadoterate meglumine Contrast Media Diagnostic Uses of Chemicals Pharmacologic Actions

ClinicalTrials.gov processed this record on March 03, 2015

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