Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

Bracco Diagnostics, Inc39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Steno-occlusive Disease

Interventions

MultihanceDRUG

0.5 Molar, single injection at 0.2 mL/kg

vasovistDRUG

0.25 molar single injection 0.03 ml/kg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bracco Imaging, S.p.A

Milan, Italy

Outcomes

Primary Outcomes

Sensitivity and specificity compared to DSA

Time frame: post dose

Secondary Outcomes

accuracy and predictive values; inter-reader agreement for diagnostic performance

Time frame: post dose

Data from ClinicalTrials.gov

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