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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

Within 6 weeks after MRM

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

91782

NCT ID:

NCT01104584

Start Date:

May 2010

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Gadobutrol-enhanced MRI
  • Mammography
  • Diagnostic Imaging
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Phoenix, Arizona  85012
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
Denver, Colorado  
Providence, Rhode Island  02908