Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
NCT ID: NCT01104584
Last Updated: 2014-11-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gadobutrol (Gadavist, BAY86-4875)
Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) \[0.1 ml/kg bw\] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight
Interventions
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Gadobutrol (Gadavist, Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
Oakland, California, United States
Englewood, Colorado, United States
Chicago, Illinois, United States
New York, New York, United States
Columbus, Ohio, United States
Providence, Rhode Island, United States
San Antonio, Texas, United States
Tacoma, Washington, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Göttingen, Lower Saxony, Germany
Göttingen, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Bochum, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Gera, Thuringia, Germany
Berlin, , Germany
Mumbai, Maharashtra, India
Delhi, , India
Mumbai, , India
Eindhoven, EJ, Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Bydgoszcz, , Poland
Gliwice, , Poland
Krakow, , Poland
Szczecin, , Poland
Warsaw, , Poland
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Girona, Girona, Spain
Alzira, Valencia, Spain
Córdoba, , Spain
Taipei, Taiwan, Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taizung, , Taiwan
Countries
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References
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Endrikat J, Schmidt G, Haverstock D, Weber O, Trnkova ZJ, Barkhausen J. Sensitivity of Contrast-Enhanced Breast MRI vs X-ray Mammography Based on Cancer Histology, Tumor Grading, Receptor Status, and Molecular Subtype: A Supplemental Analysis of 2 Large Phase III Studies. Breast Cancer (Auckl). 2022 Apr 19;16:11782234221092155. doi: 10.1177/11782234221092155. eCollection 2022.
Sardanelli F, Newstead GM, Putz B, Jirakova Trnkova Z, Trimboli RM, Abe H, Haverstock D, Rosenberg M. Gadobutrol-Enhanced Magnetic Resonance Imaging of the Breast in the Preoperative Setting: Results of 2 Prospective International Multicenter Phase III Studies. Invest Radiol. 2016 Jul;51(7):454-61. doi: 10.1097/RLI.0000000000000254.
Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2009-009598-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91782
Identifier Type: -
Identifier Source: org_study_id