Know Cancer

or
forgot password

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, Diagnostic Imaging

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:

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/1.73m2 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: Bundesinstitut für Arzneimittel und Medizinprodukte

Study ID:

91743

NCT ID:

NCT01067976

Start Date:

February 2010

Completion Date:

July 2011

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Austin, Texas  78705
Boston, Massachusetts  
Washington, District of Columbia