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Breast Magnetic Resonance Imaging

Enhancing Breast Care Together

In the US, about 1 in 8 women will develop breast cancer in their lifetime.1 MRI is an important diagnostic tool for breast cancer, and breast MRI is a high-sensitivity, radiation-free option for patients. It helps with the detection and characterization of breast disease and assessment of local disease extent, as well as guidance for biopsy and localization of lesions.2

Gadavist® (gadobutrol) injection 1 mmol/mL is the first and only GBCA specifically researched and developed for breast MRI in adult patients with two well-controlled clinical trials to assess the presence and extent of the disease.3

Please see Full Prescribing Information, including Boxed Warning, for Gadavist® injection.

Please see Important Safety Information for Gadavist®.

Gadavist® has Superior Sensitivity in Detection of Breast Cancer vs. Unenhanced MRI

Bayer demonstrated the value of Gadavist® in breast MRI in two identical Phase III clinical trials.

Clinical Trial Design Overview4

Efficacy Population: 787 Patients With Histologically Proven Breast Cancer

STANDARD OF TRUTH

Standard of Truth was determined through consensus of two study-independent physicians experienced in the breast cancer field using the following:

  • All available reports from biopsies, surgery, pathology, X-Ray mammography (XRM), and ultrasound (excluding MRI)
  • Histology for all malignant lesions
  • Ultrasound plus XRM for disease-free breast regions

BLINDED ANALYSIS

In each study, three blinded readers evaluated unenhanced and Gadavist®-enhanced breast MR with or without XRM images of each breast to determine the presence or absence of malignant disease in five regions (four quadrants and retro-areolar) for each breast. Three additional readers in each study read XRM alone.

Diagnostic Efficacy Was Measured By

  • Within-patient sensitivity: the mean of the percentage of malignant breast regions correctly interpreted for each subject3
  • Specificity: the percentage of breasts with no malignancy correctly identified (true-negative rate)3

The within-patient sensitivity of Gadavist® Breast MR was superior to that of unenhanced MRI.

The lower bound of the 95% Confidence Interval (CI) for the difference in within-subject sensitivity ranged from 19% to 42% for Study 1 and from 12% to 27% for Study 2.3

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Within-patient Sensitivity

Gadavist® breast MR demonstrated superior within-patient sensitivity (presence and extent) of malignant disease to that of unenhanced MRI for all six readers. Within-patient sensitivity for Gadavist® ranged from 80–89%.3

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Specificity

Gadavist® breast MR demonstrated breast level specificity surpassing a performance threshold of 80% in non-malignant breasts for five out of six readers.3

Readers reported statistically significant improvement in diagnostic confidence with Gadavist®-enhanced breast MR (versus unenhanced)4

Sensitivity of Gadavist® Breast MR for Detection of Malignant Breast Disease

Assessment of malignant disease was performed using region-based within-subject sensitivity. Sensitivity for each reading modality was defined as the mean of the percentage of malignant breast regions correctly interpreted for each subject. The false positive detection rates for Gadavist® breast MR ranged from 39% to 53% (95% CI Upper Bounds ranged from 44% to 58%).

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Three additional readers in each study read XRM alone. Based on this patient population, within-patient sensitivity ranged from 68% to 73% and specificity in non-malignant breasts ranged from 86% to 94% for these readers over both studies.  

The lower bound of the 95% Confidence Interval (CI) for the difference in within-subject sensitivity ranged from 19% to 42% for Study 1 and from 12% to 27% for Study 2.

Important Safety Information

Overestimation of Extent of Malignant Disease in MRI of the Breast:

Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

Did you know?

The American Society of Breast Surgeons recommends considering supplemental imaging (e.g. breast MRI) in addition to annual mammography for women with dense breast tissue, especially women with C and D density*5

*Class C or 3 density = heterogeneously dense; Class D or 4 density = extremely dense

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GADAVIST® IMPORTANT SAFETY INFORMATION AND INDICATIONS

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WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadavist is not approved for intrathecal use.

Nephrogenic Systemic Fibrosis

GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Gadavist in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk of NSF appears highest among patients with:

  • Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
  • Acute kidney injury

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.

 

Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported with Gadavist® and may be characterized by severe hypoxemia requiring oxygen support and mechanical ventilation. Onset can occur within <30 minutes to 24 hours after administration.  For patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.

 

Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

 

Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.

 

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).

 

INDICATIONS AND USAGE

Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):

  • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
  • To assess the presence and extent of malignant breast disease in adult patients.
  • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

Gadavist® is indicated for use in magnetic resonance angiography (MRA):

  • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

Please see Full Prescribing Information for Gadavist® (Vials and Syringes).

Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).

Consulte la información de prescripción completa para Gadavist®.

Medication Guide

Guía del Medicamento

References:

  1. American Cancer Society. (2024, September 9). Breast density and your mammogram report. American Cancer Society. https://www.cancer.org/breast-density-mammogram.
  2. American College of Radiology. ACR Practice Guideline for the Performance of Contrast-enhanced Magnetic Resonance Imaging (MRI ) of the Breast. https: / /www .acr .org /- /media /ACR /Files /Practice-Parameters /mr-contrast-breast .pdf. Accessed March 31, 2020.
  3. Gadavist [Package insert]. Whippany, NJ: Bayer HealthCare Pharmaeuticals Inc; 2025.
  4. Data on File. Bayer HealthCare.
 

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Last update:  April 2025

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