Renal Disease
Conditions
Keywords
Renal disease, Contrast agent, MRA
Brief summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Detailed description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Interventions
DRUGDotarem
Each subject will receive one injection of Dotarem 0.2ml/kg
OTHERTime of Flight
Each subject will undergo a TOF MRA
Sponsors
Guerbet
Study design
Allocation
NON_RANDOMIZED
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 renal arterial disease * Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography 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 |
|---|---|---|
| Percent of Non Assessable Renal Artery Segments | 1 to 7 days | For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared |
Countries
United States
Participant flow
Recruitment details
The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.
Pre-assignment details
Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study
Participants by arm
| Arm | Count |
|---|---|
| TOF Followed by Dotarem-enhanced MRA Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg). | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | TOF Followed by Dotarem-enhanced MRA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 16 |
| Region of Enrollment Canada | 6 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percent of Non Assessable Renal Artery Segments
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Time frame: 1 to 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dotarem-enhanced MRA | Percent of Non Assessable Renal Artery Segments | 25 percentage of non-assessable segments |
| Time-Of-Flight MRA | Percent of Non Assessable Renal Artery Segments | 20 percentage of non-assessable segments |