Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI) (GEMMA 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01104584
First received: April 14, 2010
Last updated: November 6, 2013
Last verified: November 2013
  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


Condition Intervention Phase
Breast Cancer
Drug: Gadobutrol (Gadovist, BAY86-4875)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The determination of the extent of malignant disease assessed for each breast region for unenhanced Magnetic Resonance Mammography (MRM) versus combined unenhanced and gadobutrol enhanced MRM [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • The determination of the extent of malignant disease assessed for each breast region for unenhanced MRM versus combined unenhanced and gadobutrol-enhanced MRM plus X-Ray Mammography (XRM) versus unenhanced MRM plus XRM [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The determination of extent of malignant disease recorded in the same manner as for the primary variable for combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM (evaluated by investigators) [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • The determination of extent of malignant disease recorded in the same manner as for the primary variable for combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM (evaluated by investigators) [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • The determination of extent of malignant disease recorded in the same manner as for the primary variable for combined unenhanced and gadobutrol-enhanced MRM (plus XRM) versus XRM alone (evaluated by both blinded readers and the investigators) [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • Confidence in diagnosis [ Time Frame: Day of MRM ] [ Designated as safety issue: No ]
  • Multicentric malignant disease status [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • Bilateral malignant disease status [ Time Frame: Within 6 weeks after MRM ] [ Designated as safety issue: No ]
  • Safety of gadovist (vital signs, physical examination, laboratory blood and urine samples) [ Time Frame: At the baseline (day of MRI) and 24 hours post MRI ] [ Designated as safety issue: Yes ]
  • Safety of gadovist (adverse event monitoring) [ Time Frame: Through the whole study (on avarage 3 days) ] [ Designated as safety issue: Yes ]

Enrollment: 438
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • 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/1.73m2 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/1.73m2).
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104584

  Show 48 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01104584     History of Changes
Other Study ID Numbers: 91782, 2009-009598-90
Study First Received: April 14, 2010
Last Updated: November 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Taiwan: Department of Health
India: Central Drugs Standard Control Organization
Canada: Health Canada
Turkey: Ethics Committee
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United States: Food and Drug Administration

Keywords provided by Bayer:
Breast Cancer
Gadobutrol-enhanced MRI
Mammography
Diagnostic Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014