Trial Condition(s):

Breast Cancer, Diagnostic Imaging

Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast MRI

Bayer Identifier:

91743

ClinicalTrials.gov Identifier:

NCT01067976

EudraCT Number:

2009-009597-27

Study Completed

Trial Purpose

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.

Inclusion Criteria
- Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
 - If female, a digital XRM is required if any of the following criteria is met:
a. patient is younger than 50 years;
b. patient has heterogeneously or extremely dense breasts;
c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
 - If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
 - Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion Criteria
- Is a female patient who is pregnant or lactating
 - Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
 - Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
 - Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
 - Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).
 - Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
 - Has received hormone replacement therapy within 4 weeks prior to study drug administration.
 - Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application 
 - Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM

Trial Summary

Enrollment Goal
446
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Lübeck, Germany, 23538

Status
Completed
 
Locations

Investigative Site

Magdeburg, Germany, 39120

Status
Completed
 
Locations

Investigative Site

Newport Beach, United States, 92658-6100

Status
Completed
 
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Hospital Italiano Buenos Aires

Buenos Aires, Argentina, C1181ACH

Status
Terminated
 
Locations

Investigaciones Médicas

Buenos Aires, Argentina, C1082A

Status
Terminated
 
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Investigative Site

Seoul, South Korea, 150-713

Status
Completed
 
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Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
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Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45257

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45147

Status
Completed
 
Locations

Investigative Site

Marburg, Germany, 35033

Status
Completed
 
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Investigative Site

Potsdam, Germany, 14467

Status
Completed
 
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Investigative Site

Dortmund, Germany, 44263

Status
Completed
 
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Investigative Site

Bielefeld, Germany

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90033

Status
Completed
 
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Investigative Site

La Jolla, United States, 92093

Status
Completed
 
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Investigative Site

San Antonio, United States, 78229

Status
Completed
 
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Investigative Site

Springfield II, United States, 62781

Status
Completed
 
Locations

Centro de Diagnóstico Dr. Enrique Rossi

Buenos Aires, Argentina, C1425BEE

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
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Investigative Site

Milano, Italy, 20097

Status
Completed
 
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Investigative Site

Napoli, Italy, 80131

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20141

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
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Investigative Site

Bogotá, Colombia

Status
Completed
 
Locations

Investigative Site

MEDELLIN, Colombia

Status
Completed
 
Locations

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

Status
Terminated
 
Locations

Clinica de Diagnostico por Imagem

Rio de Janeiro, Brazil, 22649

Status
Terminated
 
Locations

Hospital Clínicas FMUSP

Sao Paulo, Brazil

Status
Terminated
 
Locations

Investigative Site

Gyeonggi-do, South Korea, 425-707

Status
Completed
 
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Investigative Site

Baden, Switzerland, 5404

Status
Completed
 
Locations

Investigative Site

Tampere, Finland, 33521

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20007-2197

Status
Completed
 
Locations

Docrates

Helsinki, Finland, 00180

Status
Completed
 

Trial Design