Patients with high grade carotid artery stenosis or acute cerebral ischemia
Conditions
Interventions
Trade Name: Gadovist
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadobutrol
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: mmol/kg millimole(s)/kil
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. adult patients, age 18-85 years 2. with clinically suspected or definite ischemic stroke or an intracranial stenosis (> 50% degree) or extracranial stenosis of the internal carotid artery (> 70%) 3. clinically indicated initial and follow-up MR examinations of the brain with contrast injection 4. willing to undergo and comply with all study procedures 5. written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. who are in pregnancy or nursery. In women with child bearing potential a pregnancy test must be performed directly before each MR examination in order to safely exclude pregnancy. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed. 2. with impaired renal function of CKD stadium 3 and higher (i.e. creatinine clearance < 60 ml/min/1.73m² (Cockroft-Gault formula) or patients on hemodialysis. In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. Serum creatinine value must not be older than one week (7 days) before study related contrast injection. 3. with renal or liver transplant, including patients with scheduled liver transplant 4. with known allergy or any contraindication to Gadobutrol or Gadoterate. 5. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast agent. 6. with high grade cardiac arrhythmia 7. not being able to remain lying down for at least 30-45 min (e.g., patients with unstable angina, dyspnoea at rest, severe pain at rest, severe back pain) 8. having any physical or mental status that interferes with the informed consent procedure including self-signed consent. 9. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.) 10. being clinically unstable or requiring emergency treatment 11. with close affiliation with the investigational site; e.g. a close relative of the investigator 12. who have received any investigational drug within 7 days prior to entering this study 13. who have received any contrast agent within 24 hours prior to entering this study 14. who have previously entered this study 15. participating in another clinical trial 16. having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove that Gadobutrol provides superior characteristics as compared to Gadoterate in DSC-MR perfusion imaging and contrast-enhanced MR angiography in acute stroke patients and/or patients harboring an intracranial stenosis or extracranial ICA stenosis, assessed by two independent blinded readers. ;Secondary Objective: • To assess the feasibility of a dual injection protocol in MRI in patients with acute stroke or cerebrovascular diseases. • To evaluate descriptively whether Gadobutrol enhanced study protocol provides superior information to guide and tailor further diagnostic and / or therapeutic decisions in this kind of patient population. • To evaluate descriptively whether Gadobutrol has a superior vessel contrast and contrast-to-noise ratio in CE-MRA studies (quantitative analysis). • To evaluate descriptively whether the vessel conspicuity and stenosis characterization with the use of Gadobutrol is superior (qualitative analysis) • To evaluate whether the signal drop after gadobutrol injection in DSC-MRP is superior based on a quantitative analysis of the signal intensity time curve • To assess the correlation between the cardiac ejection fraction (if available) and the DSC-MRP quality. ;Primary end point(s): All images will be evaluated for technical adequacy by on site and off site readers to check their eligibility. A blinded read will be performed off site using appropriate technology and equipment. The preparation of the reading will be adhering to international quality standards and documented accordingly. On site, the MR perfusion source data will be analyzed in a standardized way using the Siemens "MRPerf" software. This software generates color-coded parameter maps of mean transit time (MTT), time to peak (TTP), relative cerebral blood volume (rCBV) and relative cerebral blood flow (rCBF). Furthermore, a global bolus plot (GBP) is calculated, showing the time course of the global T2* signal. CE-MRA will be reconstructed on s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CE-MRA Signal-to-noise ratio will be measured for 23 supraaortic vessel segments: • - Aortic arch • - Brachiocephalic artery - Right subclavian - Right common carotid artery - Right external carotid artery - Right internal carotid artery o o Extracranial segment o Petrous segment o Lacerum segment o Cavernous segment - Right vertebral artery o o Preforaminal segment o Foraminal segment o C1 loop • - Vertebral artery - Left common carotid artery - Left external carotid artery - Left internal carotid artery o o Extracranial segment o Petrous segment o Lacerum segment o Cavernous segment • - Left subclavian - Left vertebral artery o o Preforaminal segment o Foraminal segment o C1 loop DSC-MRP As quantitative DSC-MRP parameters highly depend on the current circulation status of the patient, no quantitative assessment will be performed. ;Timepoint(s) of evaluation of this end point: In a blinded read after the inclusion of all subjects | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Arnd Dörfler
University Hospital Erlangen
Outcome results
None listed