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Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

Phase 2
Completed
Conditions
Magnetic Resonance Angiography
Peripheral Vascular Diseases
Peripheral Arterial Diseases
Interventions
Registration Number
NCT00652418
Lead Sponsor
Bayer
Brief Summary

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria
  • Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
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Exclusion Criteria
  • Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
  • Patients with allergy to contrast media
  • Patients with serious hepatic impairment
  • Patients with serious renal impairment
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Arm 1Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)-
Arm 2Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)-
Primary Outcome Measures
NameTimeMethod
Diagnostic abilityMRI image in blinded read
Secondary Outcome Measures
NameTimeMethod
VisibilityMRI image in blinded read
Diagnostic confidenceMRI image in blinded read
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