Trial Condition(s):

Breast Cancer

Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast magnetic resonance imaging (MRI) (GEMMA 2)

Bayer Identifier:

91782

ClinicalTrials.gov Identifier:

NCT01104584

EudraCT Number:

2009-009598-90

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
460
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

Greifswald, Germany, 17489

Status
Completed
 
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Investigative Site

München, Germany, 81377

Status
Completed
 
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Berlin, Germany, 10115

Status
Completed
 
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Frankfurt, Germany, 60596

Status
Completed
 
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Columbus, United States, 43212

Status
Completed
 
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Tacoma, United States, 98321

Status
Completed
 
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Gliwice, Poland, 44-100

Status
Completed
 
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Barcelona, Spain, 08036

Status
Completed
 
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Cordoba, Spain, 14004

Status
Completed
 
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Montreal, Canada, H4J 1C5

Status
Completed
 
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Erlangen, Germany, 91054

Status
Completed
 
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Chicago, United States, 60637

Status
Completed
 
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San Antonio, United States, 78229

Status
Completed
 
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Krakow, Poland, 30-501

Status
Completed
 
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Szczecin, Poland, 70-111

Status
Completed
 
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Sabadell, Spain, 08208

Status
Completed
 
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Alzira, Spain

Status
Completed
 
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Girona, Spain, 17002

Status
Completed
 
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Toronto, Canada, M5G 2M9

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Completed
 
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Buenos Aires, Argentina, C1425BEE

Status
Completed
 
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Buenos Aires, Argentina, C1082A

Status
Completed
 
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Delhi, India, 110085

Status
Completed
 
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Taipei, Taiwan, China, 100

Status
Completed
 
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Taipei, Taiwan, China, 114

Status
Completed
 
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Taipei, Taiwan, China, 110

Status
Completed
 
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Buenos Aires, Argentina, C1181ACH

Status
Completed
 
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Mumbai, India, 400012

Status
Completed
 
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Mumbai, India, 400 004

Status
Completed
 
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Taichung, Taiwan, China

Status
Completed
 
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Taizung, Taiwan, China, 402

Status
Completed
 
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Oakland, United States, 94609

Status
Completed
 
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Tucson, United States, 85724

Status
Completed
 
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Englewood, United States, 80112

Status
Completed
 
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Toronto, Canada, M5S 1B2

Status
Completed
 
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Gera, Germany, 07548

Status
Completed
 
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Investigative Site

Münster, Germany, 48145

Status
Completed
 
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Investigative Site

Göttingen, Germany, 37075

Status
Completed
 
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Investigative Site

Bydgoszcz, Poland, 85-796

Status
Completed
 

Trial Design