Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
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ClinicalTrials.gov Identifier: NCT00845702 |
Recruitment Status :
Terminated
(lack of recruitment.)
First Posted : February 18, 2009
Results First Posted : September 19, 2012
Last Update Posted : May 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Renal Artery Stenosis | Drug: Gadoterate meglumine (Dotarem) Other: Time of Flight Magnetic Resonance Angiography | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2 ml/kg.
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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
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Other: Time of Flight Magnetic Resonance Angiography
Each subject will undergo a TOF MRA |
- Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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,

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845702
United States, Indiana | |
Guerbet LLC | |
Bloomington, Indiana, United States, 47403 |
Responsible Party: | Guerbet |
ClinicalTrials.gov Identifier: | NCT00845702 |
Other Study ID Numbers: |
DGD-44-046 |
First Posted: | February 18, 2009 Key Record Dates |
Results First Posted: | September 19, 2012 |
Last Update Posted: | May 20, 2016 |
Last Verified: | April 2016 |
Renal artery stenosis Contrast agent MRA |
Renal Artery Obstruction Kidney Diseases Urologic Diseases Arterial Occlusive Diseases Vascular Diseases |
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