Multihance versus Dotarem at 3 Tesla

Breast lesion detection and characterization at contrast-Enhanced MRI of the breast: comparison of gadoterate meglumine versus gadobenate dimeglumine at 3 Tesla

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005498-21-AT

Enrollment

130

Registered

2012-05-31

Start date

2012-07-12

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the aim of this study is to intraindividually compare the use of equivalent doses of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, France) for breast MR imaging by using a prospective study design, evaluated independently by blinded readers.

Interventions

Trade Name: MultiHance Pharmaceutical Form: Solution for infusion CAS Number: 113662-23-0 Other descriptive name: GADOBENATE DIMEGLUMINE Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with mammographycally and/or sonographically detected abnormalities classified as category BI-RADS 4 or 5 will be enrolled in this prospective study. All enrolled patients will provide written informed consent for both the study and the following elaboration of data. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they are younger than 18 years old; are high risk patients; are pregnant or lactating; have a confirmed breast malignancy ; or are undergoing radiation therapy, chemotherapy or anticancer hormonal therapy for a known cancer, or if they received any other MR contrast agent during the 48 hours before the contrsat agent administration in our study. Patients who have any contraindications for MR examinations (eg, pacemaker, metallic implants) or with a history of hypersensitivity to gadolinium chelates will also be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to intraindividually compare the use of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, France) for breast MR imaging by using a prospective study design, evaluated independently by blinded readers.;Secondary Objective: ;Primary end point(s): Sensitivity;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The aim of this study is to intraindividually compare the use of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, France) for breast MR imaging by using a prospective study design, evaluated independently by blinded readers.;Secondary Objective: ;Primary end point(s): Sensitivity;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Specificity, Accuracy, Signal to Noise Ratio;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026