Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01104584

Run by

Bayer

People needed

460

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2014-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Oakland, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Chicago, Illinois, United States
• Study site — New York, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Providence, Rhode Island, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Hamilton, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Erlangen, Bavaria, Germany
• Study site — München, Bavaria, Germany
• Study site — Frankfurt am Main, Hesse, Germany
• Study site — Göttingen, Lower Saxony, Germany
• Study site — Göttingen, Lower Saxony, Germany
• Study site — Greifswald, Mecklenburg-Vorpommern, Germany
• Study site — Bochum, North Rhine-Westphalia, Germany
• Study site — Münster, North Rhine-Westphalia, Germany
• Study site — Münster, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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