Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
Condition: Breast Cancer; Diagnostic Imaging
MeSH terms: Breast Neoplasms
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention description: A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Gadobutrol-enhanced MRI; Mammography

Summary:

      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.
    

Eligibility criteria:

        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:

               1. patient is younger than 50 years;

               2. patient has heterogeneously or extremely dense breasts;

               3. 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