INTRAINDIVIDUAL CROSS-OVER STUDY TO COMPARE MULTIHANCE® AND MAGNEVIST® AT A DOSE OF 0.1 MMOL/KGBW IN CERVICO-CEREBRAL MR ANGIOGRAPHY AND CEREBRAL MR PERFUSION IMAGING AT 3 TESLA IN PATIENTS WITH CAROTID ARTERY STENOSIS

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Autores
Categoría Estudio primario
Registro de estudiosEU Clinical Trials Register
Año 2006
INTERVENTION: Trade Name: MultiHance Pharmaceutical Form: Solution for injection INN or Proposed INN: Gadobenate Dimeglumine CAS Number: 113662‐23‐0 Concentration unit: mol/l mole(s)/litre Concentration type: equal Concentration number: 0,5‐ Trade Name: Magnevist Pharmaceutical Form: Solution for injection INN or Proposed INN: GADOPENTETATE DIMEGLUMINE CAS Number: 86050‐77‐3 Concentration unit: mol/ml mole(s)/millilitre Concentration type: equal Concentration number: 0,5‐ CONDITION: Carotid artery stenosis and scheduled for MRA, for MR perfusion examination and for an elective stent treatment ; MedDRA version: 8.1 Level: LLT Classification code 10007687 Term: Carotid artery stenosis PRIMARY OUTCOME: Main Objective: To show the superiority of MultiHance® over Magnevist® in the quality of vascular delineation of supraaortic vessels in 3T CE‐MRA.; Primary end point(s): The individual mean of vessel delineation scores over all evaluable arterial segments (scores 1‐5) of a patient as determined in on‐site separate assessments of MRA. Secondary Objective: To compare the contrasting behavior of MultiHance® and Magnevist®:; ; · in 3T CE‐MRA with regard to:; ‐ Image quality;; ‐ Signal intensity measurements; ; ‐ Determination of the grade and length of the target stenosis (in comparison with DSA results); ; · in 3T MR perfusion imaging with regard to:; ‐ Perfusion quantitative parameters.; ; To compare DSA and 3T CE‐MRA (accuracy analysis) in terms of:; ‐ Grade of the target stenosis;; ‐ Detection/grade of additional stenoses of cerebral arteries.; ; To compare MRI findings pre‐ and post stent implantation:; ‐ Change (normalization) in perfusion deficits;; ‐ Delineation of cerebral arteries. INCLUSION CRITERIA: 1. Patient suffers from a stenosis of the internal carotid artery (ICA), is scheduled for MRA, for MR perfusion examination and for an elective stent treatment; 2. Patient is adult (age, > or =18 years), conscious and co‐operative; 3. Patient provides written Informed Consent to participate in the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: fb9378eea4189eee6f8dae73d2aaf79cb044d090
First added on: Aug 21, 2024