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The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem and TOF MRA | Experimental | Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem | Drug | Each subject will receive one injection of Dotarem 0.2ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Failure Rate | Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060). | 2 - 28 days |
| Sensitivity | Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | 2-42 days |
| Specificity | Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | 2 - 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre DESCHE, MD | Guerbet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guerbet LLC | Bloomington | Indiana | 47403 | United States |
A total of 222 patients fulfilling the eligibility criteria were enrolled, of which 200 patients received Dotarem and completed the study. Twenty-two patients did not receive Dotarem and were discontinued prematurely.
First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments
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| ID | Title | Description |
|---|---|---|
| FG000 | TOF MRA Followed by Dotarem-enhanced MRA | Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA. Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TOF MRA Followed by Dotarem-enhanced MRA | Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA. Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth. |
| 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 | Technical Failure Rate | Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060). | For 2 patients, MRA images were not analyzed because images were incomplete. | Posted | Number | 95% Confidence Interval | percentage of arterial segments | 2 - 28 days | arterial segments | Participants |
|
Adverse events were collected since the patient signing the patient consent form till the end of the last visits, maximum duration is 42 days.
Adverse Events reported during the 24 hours following TOF, 24 hours following Dotarem-enhanced MRA and 24 hours following CTA and Adverse Events in discontinued patients without Dotarem administration are described. Participants at risk were subjects exposed to Dotarem administration.
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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 MRA | Patients benefiting from a MR angiography after an IV administration of Dotarem |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment | not related to Dotarem administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site hematoma | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs | Guerbet | +33 1 45 91 50 00 | pierre.desche@guerbet-group.com |
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| ID | Term |
|---|---|
| D002539 | Cerebral Arterial Diseases |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| TOF MRA | Other | Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA) |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| arterial segments |
|
|
| Primary | Sensitivity | Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure. | Posted | Number | 95% Confidence Interval | percentage of stenotic segments | 2-42 days | number of arterial segments | Participants |
|
|
|
| Primary | Specificity | Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure. | Posted | Number | 95% Confidence Interval | percentage of non-stenotic segments | 2 - 42 days | Number of arterial segments | Participants |
|
|
|
| 1 |
| 200 |
| 12 |
| 200 |
| EG001 | TOF MRA | Patients benefiting from a MR angiography with no contrast medium administration | 0 | 200 | 0 | 200 |
| EG002 | Computerized Tomography Angiography (CTA) | Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium | 2 | 200 | 7 | 200 |
| EG003 | Patients Discontinued Without Dotarem Administration | Patients withdrawn before administration of Dotarem whatever the reason | 1 | 22 | 2 | 22 |
|
| Chest Pain | General disorders | Systematic Assessment | not related to Dotarem administration |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment | not related to Dotarem administration |
|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment | not related to Dotarem administration |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Neutrophil Count increased | Investigations | Systematic Assessment |
|
| Lymphopenia | Investigations | Systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Reader 3 |
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| Reader 3 |
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