Trial Condition(s):
Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast magnetic resonance imaging (MRI) (GEMMA 2)
91782
Not Available
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
- 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.
- 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
Locations | Status | |
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Locations Investigative Site Greifswald, Germany, 17489 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60596 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43212 | Status Completed | Contact Us: E-mail: clinical-trials-contac[email protected] Phone: Not Available |
Locations Investigative Site Tacoma, United States, 98321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gliwice, Poland, 44-100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cordoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H4J 1C5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 30-501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 70-111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alzira, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Girona, Spain, 17002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425BEE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1082A | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Delhi, India, 110085 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1181ACH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mumbai, India, 400012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mumbai, India, 400 004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taichung, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taizung, Taiwan, China, 402 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oakland, United States, 94609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Englewood, United States, 80112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5S 1B2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gera, Germany, 07548 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-796 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1