Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

• Sponsor: Bracco Diagnostics, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00415805
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 26.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Condition or Disease	Intervention/Treatment	Phase
Steno-Occlusive Disease	Drug: Multihance; Drug: vasovist	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Pilot, Open-Label, Multicenter Intra-Individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Multihance; 0.5 Molar, single injection at 0.2 mL/kg
Active Comparator: 2	Drug: vasovist; 0.25 molar single injection 0.03 ml/kg

Outcome Measures

Primary Outcome Measures

1. Sensitivity and specificity compared to DSA [post dose]

Secondary Outcome Measures

1. accuracy and predictive values; inter-reader agreement for diagnostic performance [post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Known or suspected renovascular disease based on one of the following criteria:

• severe hypertension

• hypertension refractory to standard therapy

• abrupt onset of moderate to severe hypertension at age < 35 years

• normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension

• unexplained by stable elevation of serum creatinine > 2Mg/dL

• positive findings for stenosis from another imaging modality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bracco Imaging, S.p.A	Milan		Italy	20134

Sponsors and Collaborators

• Bracco Diagnostics, Inc

Investigators

• Study Director: Gianpaolo Pirovano, MD, Bracco Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00415805
• Other Study ID Numbers: MH 128
• First Posted: Dec 25, 2006
• Last Update Posted: Mar 13, 2009
• Last Verified: Mar 1, 2009

Study Results

No Results Posted as of Mar 13, 2009