Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
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ClinicalTrials.gov Identifier: NCT00980681 |
Recruitment Status
:
Terminated
(Lack of recruitment.)
First Posted
: September 21, 2009
Results First Posted
: May 26, 2016
Last Update Posted
: May 26, 2016
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Sponsor:
Guerbet
Information provided by (Responsible Party):
Guerbet
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Tracking Information | ||||
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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 | |||
Study Start Date ICMJE | September 2009 | |||
Actual 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
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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 |
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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 |
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Condition ICMJE | Renal Disease | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
13 | |||
Original Estimated Enrollment ICMJE |
220 | |||
Actual Study Completion Date | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | No | |||
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 |
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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 |