Multihance Versus Magnevist in Breast MRI

Bracco Diagnostics, Inc130 enrolled

Overview

To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

130

Conditions

Breast Cancer

Interventions

MultihanceDRUG

0.5 Molar at a single dose injection

MagnevistDRUG

0.5M at a single dose injection

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provides written informed consent * Female * Age 18 years or older * Suspicious or known breast lesion based on results from mammography or ultrasound * Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam Exclusion Criteria: * Body weight \> 100 kg * Pregnant or lactating * Server or end-stage organ failure * Moderate to severe renal impairment * Undergoing radiotherapy or completed radiotherapy in the last 18 months * Chemotherapy within 6 months of the 1st MRI exam

Locations (1)

Unnamed facility

Rome, Italy

Outcomes

Primary Outcomes

Sensitivity in diagnosing breast lesions compared to histopathology results

Time frame: up to 6 months

Secondary Outcomes

Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels

Time frame: up to 6 months

Data from ClinicalTrials.gov

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