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This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem / Gadovist | Experimental | Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Dotarem in period 1 then with Gadovist in period 2 |
|
| Gadovist / Dotarem | Experimental | Contrast-enhanced MRA - Imaging examination contrast enhanced-MRA first with Gadovist in period 1 then with Dotarem in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced MRA - Imaging examination | Other | Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Image Quality of MRA Images | Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale:
Each image is analysed by 4 readers. | MRA examination |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Confidence | Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent. Each image is analysed by 4 readers. | MRA examination |
| Signal Intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guerbet | Guerbet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guerbet | Roissy CDG | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dotarem Then Gadovist | Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2) |
| FG001 | Gadovist Then Dotarem | Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First MRA (Between Day0 and Day21) |
| |||||||||||||
| Second MRA (Between Day 1 and Day 51) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population. |
| 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 | Overall Image Quality of MRA Images | Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale:
Each image is analysed by 4 readers. | descriptive and pilot study, no number of participants calculation performed | Posted | Number | Images | MRA examination | cases (4 evaluations per image) | Participants |
|
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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 who received a Dotarem enhanced-MRA |
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Limitation of the study: descriptive study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilie Huchet | Guerbet | +33 1 45 91 50 00 | 7688 | emilie.huchet@guerbet-group.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured. |
| MRA examination |
| NOT COMPLETED |
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|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Diagnostic Confidence | Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent. Each image is analysed by 4 readers. | Descriptive study - No calculation | Posted | Number | Images | MRA examination | cases (4 evaluations per image) | Participants |
|
|
|
| Secondary | Signal Intensity | Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured. | Posted | Mean | Standard Deviation | Ratio | MRA examination |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Gadovist MRA | Patients who received a Gadovist enhanced-MRA | 0 | 17 | 0 | 17 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |