Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

NCT ID: NCT01067976

Last Updated: 2014-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-01-31

Brief 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.

Conditions

Breast Cancer; Diagnostic Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadobutrol (Gadavist, BAY86-4875)

Patients first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw \[0.1 ml/kg bw\] as an intravenous injection (i.v.) injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.

Group Type: EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight

Interventions

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

La Jolla, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

Washington D.C., District of Columbia, United States

Springfield II, Illinois, United States

Boston, Massachusetts, United States

San Antonio, Texas, 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

Rio de Janeiro, Rio de Janeiro, Brazil

São Paulo, São Paulo, Brazil

São Paulo, , Brazil

Medellín, Antioquia, Colombia

Bogotá, Cundinamarca, Colombia

Barranquilla, , Colombia

Helsinki, , Finland

Tampere, , Finland

Tübingen, Baden-Wurttemberg, Germany

Marburg, Hesse, Germany

Hanover, Lower Saxony, Germany

Bielefeld, North Rhine-Westphalia, Germany

Dortmund, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Magdeburg, Saxony-Anhalt, Germany

Lübeck, Schleswig-Holstein, Germany

Potsdam, , Germany

San Donato Milanese, Milano, Italy

Milan, , Italy

Milan, , Italy

Napoli, , Italy

Udine, , Italy

Ansan Si, Kyungki Do, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Bern, Canton of Bern, Switzerland

Chur, Kanton Graubünden, Switzerland

Baden, , Switzerland

Countries

United States; Argentina; Brazil; Colombia; Finland; Germany; Italy; South Korea; Switzerland

References

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.

Reference Type: DERIVED

PMID: 35462754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26840494 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu

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Other Identifiers

GEMMA 1

Identifier Type: OTHER

Identifier Source: secondary_id

2009-009597-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

91743

Identifier Type: -

Identifier Source: org_study_id