Intraindividual cross-over comparison of Gadobutroland Gadoterate enhanced combined DSC-MR-Perfusion and MRAngiographyin patients with cerebrovascular disease

Phase 4

• Conditions: I67; Subjects with acute stroke and/or subjects harboring an intracranial stenosis or extracranial ICA stenosis; Other cerebrovascular diseases

• Registration Number: DRKS00009914
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-14
• Study Start: 2016-01-21
• Results First Posted: 2019-10-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. adult subjects, 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

Exclusion Criteria

Subjects …
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 subjects on hemodialysis. In subjects 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 severe hepatic impairment (SGPT > 2 x upper limit value)
4. with renal or liver transplant, including subjects with scheduled liver transplant
5. with known allergy or any contraindication to Gadobutrol or Gadoterate.
6. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast
media.
7. with high grade cardiac arrhythmia
8. not being able to remain lying down for at least 30-45 min (e.g., subjects with unstable
angina, dyspnoea at rest, severe pain at rest, severe back pain)
9. having any physical or mental status that interferes with the informed consent procedure
including self-signed consent.
10. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.)
11. being clinically unstable or requiring emergency treatment
12. with close affiliation with the investigational site; e.g. a close relative of the investigator
13. who have received any investigational drug within 7 days prior to entering this study
14. who have received any contrast media within 24 hours prior to entering this study
15. who have previously entered this study
16. participating in another clinical trial
17. having an underlying disease or concomitant medication which may interfere with
efficacy evaluation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Gadobutrol to Gadoterate in DSC-MRperfusion imaging and contrast-enhanced MR<br>angiography in acute stroke subjects and/or subjects<br>harboring an intracranial stenosis or extracranial ICA<br>stenosis<br><br>All MRI images will be evaluated for technical adequacy by on site and off site readers to check<br>their eligibility. A blinded read will be performed off site using appropriate technology and<br>equipment. The preparation of the reading will be adhering to international quality standards<br>and documented accordingly. On site, the MR perfusion source data will be analyzed in a<br>standardized way using the Siemens MRPerf software.

Secondary Outcome Measures

Name	Time	Method
To assess the feasibility of a dual injection protocol in MRI<br>in subjects with acute stroke or cerebrovascular diseases; based on qualitative image analysis in the blinded<br>read.<br>· To evaluate descriptively whether Gadobutrol enhanced<br>study protocol provides superior information to guide and<br>tailor further diagnostic and / or therapeutic decisions in<br>this kind of subject population.<br>· To evaluate descriptively whether Gadobutrol has a<br>superior vessel contrast and contrast-to-noise ratio in CEMRA<br>studies (quantitative analysis).<br>· To evaluate descriptively whether the vessel conspicuity<br>and stenosis characterization with the use of Gadobutrol<br>is superior (qualitative analysis).<br>· To evaluate whether the signal drop after gadobutrol<br>injection in DSC-MRP is superior based on a quantitative<br>analysis of the signal intensity time curve.<br>· To assess the correlation between the cardiac ejection<br>fraction (if available) and the DSC-MRP quality.