Peripheral Arterial Disease
Conditions
Keywords
Dotarem, Gadovist, Peripheral arterial disease, MRA
Brief summary
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.
Interventions
OTHERContrast-enhanced MRA - Imaging examination
Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female or male, aged ≥ 18 years * Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
Exclusion criteria
* Patients with severely impaired renal function with an eGFR (MDRD) \< 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days). * Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures. * Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Image Quality of MRA Images | MRA examination | Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Confidence | MRA examination | 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. |
| Signal Intensity | MRA examination | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second MRA (Between Day 1 and Day 51) | conventional angiography | 1 | 0 |
| Second MRA (Between Day 1 and Day 51) | Lost to Follow-up | 0 | 1 |
| Second MRA (Between Day 1 and Day 51) | technical incident | 0 | 1 |
| Second MRA (Between Day 1 and Day 51) | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age Continuous | 61.5 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Germany | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers.
Time frame: MRA examination
Population: descriptive and pilot study, no number of participants calculation performed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dotarem | Overall Image Quality of MRA Images | 56 Images |
| Gadovist | Overall Image Quality of MRA Images | 48 Images |
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.
Time frame: MRA examination
Population: Descriptive study - No calculation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dotarem | Diagnostic Confidence | 55 Images |
| Gadovist | Diagnostic Confidence | 50 Images |
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.
Time frame: MRA examination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dotarem | Signal Intensity | 23 Ratio | Standard Deviation 10 |
| Gadovist | Signal Intensity | 26 Ratio | Standard Deviation 11 |