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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00652418
• Collaborator: (none)
• Enrollment: 12
• Locations: 3
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Magnetic Resonance Angiography; Peripheral Vascular Diseases; Peripheral Arterial Diseases	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Oct 1, 2004
• Actual Study Completion Date: Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A); Magnevist at a dose of 0.1 mmol/kg
Experimental: Arm 2	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A); Magnevist at a dose of 0.2 mmol/kg

Outcome Measures

Primary Outcome Measures

1. Diagnostic ability [MRI image in blinded read]

Secondary Outcome Measures

1. Visibility [MRI image in blinded read]

2. Diagnostic confidence [MRI image in blinded read]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hirosaki-shi	Aomori	Japan	036-8563
2		Funai-gun	Kyoto	Japan	629-0197
3		Hamamatsu-shi	Shizuoka	Japan	431-3192

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00652418
• Other Study ID Numbers: 91396; 308612
• First Posted: Apr 3, 2008
• Last Update Posted: Oct 14, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Bayer: Magnevist; Magnetic Resonance Angiography; Meglumine gadopentetate; Determination of effective dose in MRA
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases

Study Results

No Results Posted as of Oct 14, 2013