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lack of recruitment.
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The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem | Experimental | Each subject will receive one injection of Dotarem 0.2 ml/kg. |
|
| Time Of Flight Magnetic Resonance Angiography | Other | Each subject undergo a TOF MRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoterate meglumine (Dotarem) | Drug | Each subject will receive one injection of Dotarem 0.2 ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared | 1 to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guerbet LLC | Bloomington | Indiana | 47403 | United States |
Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.
First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers
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| ID | Title | Description |
|---|---|---|
| FG000 | TOF Followed by Dotarem-enhanced MRA | Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOF MRA |
| |||||||||||||
| Dotarem MRA |
|
Baseline measures were recorded for all 33 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | TOF and Dotarem Enhanced MRA | Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared | The study has been prematurely terminated, and the planned analyses were not done | Posted | 1 to 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dotarem Magnetic Resonance Angiography | Each subject will receive one injection of Dotarem 0.2 ml/kg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental status changed | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Investigation | Investigations | Non-systematic Assessment |
The study was not completed due to poor enrollment. The statistical analysis was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierre Desche, MD, Head of Clinical and Regulatory Affairs | Guerbet | +33 1 45 91 50 00 | pierre.desche@guerbet-group.com |
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| Time of Flight Magnetic Resonance Angiography | Other | Each subject will undergo a TOF MRA |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 1 |
| 32 |
| 6 |
| 32 |
| EG001 | Time Of Flight MRA | Subjects undergo a TOF MRA | 0 | 32 | 0 | 32 |
| General disorders | General disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |