Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries

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.

Study Overview

• Status: Completed
• Conditions: Steno-occlusive Disease
• Intervention / Treatment: Drug: Multihance; Drug: vasovist

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20134
    • Bracco Imaging, S.p.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity compared to DSA	post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
accuracy and predictive values; inter-reader agreement for diagnostic performance	post dose

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Investigators: Study Director: Gianpaolo Pirovano, MD, Bracco Diagnostics

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 22, 2006
• First Submitted That Met QC Criteria: December 23, 2006
• First Posted (Estimated): December 25, 2006

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: MH 128