Cerebral Arterial Diseases
Conditions
Keywords
carotid or vertebral artery disease, Contrast agent, MRA
Brief summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
Detailed description
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Interventions
Sponsors
Guerbet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged more than 18 years * Strongly suspected of having carotid or vertebral arterial disease * Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination
Exclusion criteria
* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²) * Contraindication to MRI * Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Failure Rate | 2 - 28 days | 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). |
| Sensitivity | 2-42 days | 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). |
| Specificity | 2 - 42 days | 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). |
Countries
United States
Participant flow
Recruitment details
First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 222 |
| Total | 222 |
Baseline characteristics
| Characteristic | TOF MRA Followed by Dotarem-enhanced MRA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 114 Participants |
| Age, Categorical Between 18 and 65 years | 108 Participants |
| Age, Continuous | 64.8 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Argentina | 48 participants |
| Region of Enrollment Chile | 1 participants |
| Region of Enrollment Colombia | 35 participants |
| Region of Enrollment Korea, Republic of | 39 participants |
| Region of Enrollment Mexico | 18 participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 200 | 0 / 200 | 7 / 200 | 2 / 22 |
| serious Total, serious adverse events | 1 / 200 | 0 / 200 | 2 / 200 | 1 / 22 |
Outcome results
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).
Time frame: 2-42 days
Population: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dotarem-enhanced MRA | Sensitivity | Reader 1 | 58.46 percentage of stenotic segments |
| Dotarem-enhanced MRA | Sensitivity | Reader 2 | 63.08 percentage of stenotic segments |
| Dotarem-enhanced MRA | Sensitivity | Reader 3 | 53.85 percentage of stenotic segments |
| TOF MRA | Sensitivity | Reader 1 | 53.85 percentage of stenotic segments |
| TOF MRA | Sensitivity | Reader 2 | 63.08 percentage of stenotic segments |
| TOF MRA | Sensitivity | Reader 3 | 49.23 percentage of stenotic segments |
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).
Time frame: 2 - 42 days
Population: For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dotarem-enhanced MRA | Specificity | Reader 1 | 98.13 percentage of non-stenotic segments |
| Dotarem-enhanced MRA | Specificity | Reader 2 | 98.51 percentage of non-stenotic segments |
| Dotarem-enhanced MRA | Specificity | Reader 3 | 98.63 percentage of non-stenotic segments |
| TOF MRA | Specificity | Reader 1 | 85.43 percentage of non-stenotic segments |
| TOF MRA | Specificity | Reader 2 | 90.39 percentage of non-stenotic segments |
| TOF MRA | Specificity | Reader 3 | 90.42 percentage of non-stenotic segments |
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).
Time frame: 2 - 28 days
Population: For 2 patients, MRA images were not analyzed because images were incomplete.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dotarem-enhanced MRA | Technical Failure Rate | Reader 1 | 4.65 percentage of arterial segments |
| Dotarem-enhanced MRA | Technical Failure Rate | Reader 2 | 1.77 percentage of arterial segments |
| Dotarem-enhanced MRA | Technical Failure Rate | Reader 3 | 2.20 percentage of arterial segments |
| TOF MRA | Technical Failure Rate | Reader 1 | 29.44 percentage of arterial segments |
| TOF MRA | Technical Failure Rate | Reader 2 | 16.70 percentage of arterial segments |
| TOF MRA | Technical Failure Rate | Reader 3 | 18.54 percentage of arterial segments |