None listed
Conditions
Interventions
Intervention1: Gadobutrol (Gadovist, BAY86-4875): A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight
Control Intervention1: NIL: NIL
Sponsors
Bayer Schering Pharma,Berlin,Germany.
Eligibility
Inclusion criteria
Inclusion 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: patient is younger than 50 years; patient has heterogeneously or extremely dense breasts; 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/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion criteria
Exclusion criteria: 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/1.73m2). 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus . 2.Superiority of combined unenhanced and gadobutrol-enhanced MRM plus XRMTimepoint: Histologically confirmed breast cancer patients referred for MRM after XRM prior to breast surgery. 1. For patients not scheduled for ultrasound examination the study will end up with the 24-hour follow up. 2. The report of XRM findings used for inclusion and documentation of histopathology up to 6 weeks after administration of study drug will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM 2. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM 3. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus XRM alone The derived secondary efficacy variables will be: &#8722; Multicentric malignant disease status; &#8722; Bilateral malignant disease status.Timepoint: Histologically confirmed breast cancer patients referred for MRM after XRM prior to breast surgery. 1. For patients scheduled for ultrasound examination the study will end up after the ultrasound examination is finished. 2. The report of XRM findings used for inclusion and documentation of histopathology up to 6 weeks after administration of study drug will be collected. | — |
Countries
India
Contacts
Public ContactDr. Manish Garg
Country Medical Director India
Outcome results
None listed