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

This study has been terminated.

(Lack of recruitment.)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00980681

First Posted: September 21, 2009

Last Update Posted: May 26, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Guerbet

Tracking Information

First Submitted Date ^ICMJE

September 17, 2009

First Posted Date ^ICMJE

September 21, 2009

Results First Submitted Date

July 24, 2015

Results First Posted Date

May 26, 2016

Last Update Posted Date

May 26, 2016

Start Date ^ICMJE

September 2009

Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]

For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

Original Primary Outcome Measures ^ICMJE

Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ]

Change History

Complete list of historical versions of study NCT00980681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Blood sampling [ Time Frame: 24 hours ]
Tolerance at the injection site [ Time Frame: 24 hours ]
Adverse events [ Time Frame: 0 - 58 days ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

Renal Disease

Intervention ^ICMJE

Drug: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg

Other Name: gadoteric acid, gadoterate meglumine
Other: Time of Flight
Each subject will undergo a TOF MRA

Study Arms

Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg.

Intervention: Drug: Dotarem
Time Of Flight
Each subject will undergo a TOF Magnetic Resonance Angiography

Intervention: Other: Time of Flight

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00980681

Other Study ID Numbers ^ICMJE

DGD-44-047

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Guerbet

Study Sponsor ^ICMJE

Guerbet

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pierre DESCHE, MD

Guerbet

PRS Account

Guerbet

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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