Program Description

Dynamic contrast-enhanced breast MR imaging using gadolinium-based contrast agents (GBCAs) offers superior cancer detection to mammography and breast ultrasound due to the visualization of tumor neovascularity as a tumor-specific feature. Despite the clear advantages of breast MR imaging, it is currently recommended only for patients with a high lifetime risk of breast cancer, but recent data shows that there is also a benefit for women at a greater than average risk.

While GBCAs are essential to performing breast MR imaging, guidance from the US Food and Drug Administration (FDA) and the American College of Radiology (ACR) includes the recommendation of limiting a patient's gadolinium exposure where possible. One technique for reducing gadolinium exposure is to use a high-relaxivity GBCA that can be administered at a lower dose than a conventional GBCA without deteriorating image quality. Gadopiclenol recently received FDA approval and is a high-relaxivity GBCA that decreases gadolinium exposure.

This educational program provides a clinical rationale for lowering the administered gadolinium dose when performing breast MRI on patients who may receive repeat MR contrasted exams throughout their lifetime for breast cancer screening. Through a review of case studies, Dr. Pinker-Domenig will provide insight on how to achieve optimal imaging while lowering the gadolinium dose with Gadopiclenol for breast MRI.

Learning Objectives

At the completion of this activity, participants will be able to:

Understand and employ the clinical indications for dynamic-contrast enhanced breast MRI.
Access clinical considerations and apply lower gadolinium dosing options for patients who may experience repeat, lifetime dosing of a GBCA for breast MRI.
Implement breast MR imaging protocols to achieve the most accurate breast cancer diagnosis.

Educational Credits

One (1) ARRT Category A CE Credit
One (1) AHRA CRA Credit

Target Audience

MRI Technologists
Radiology Administrators
Related Imaging Professionals

Speaker

Katja Pinker-Domenig, MD, PhD, EBBI, FISMRM, FSBI
Memorial Sloan Kettering Cancer Center

Katja Pinker-Domenig, MD, PhD, recently named Division Chief of Breast Imaging at the Department of Radiology at Columbia University Vagelos College of Physicians and Surgeons (VP&S) (May 2024), is an internationally renowned physician-scientist and board-certified radiologist with extensive expertise in all aspects of state-of-the-art breast imaging, including mammography, digital breast tomosynthesis, ultrasound, MRI, and breast interventions.

She has special training in the use of imaging to diagnose and treat disease with a focus on research and advanced medical imaging. Her top clinical accomplishments include the successful use of multiparametric MRIs in routine patient care; a concept that she developed, investigated, and implemented in Vienna and further refined at Memorial Sloan Kettering Cancer Center (MSK) to achieve the most accurate breast cancer detection.

Before joining MSK, Dr. Pinker-Domenig trained and practiced at the Medical University of Vienna in Austria. With a strong interest in cancer research that uses advanced imaging, she joined MSK in 2014 as a researcher, and has been a member of the radiology team at Memorial Hospital since November 2017, as well as a professor of radiology at Weill Medical College of Cornell University since November 2020. Until September, Dr. Pinker-Domenig will serve as the Director of Research and the Director of Breast MRI for the Breast Imaging Service in MSK’s Department of Radiology. She is an Executive Board Member of the nonprofit European Society of Breast Imaging and has co-authored several guidelines addressing all aspects of breast cancer imaging.

Disclosures

Presenter

Katja Pinker-Domenig, MD discloses the following relationships and financial interests:

AURA Health Technologies GmbH- Consultant
Bayer - Consultant
European Society of Breast Imaging (EUSOBI)- Speaker
Merantix Healthcare GmbH (ended)- Consultant
Neodynamics Inc.- Consultant

Accreditation Statement

Radiologic Technologist

This course meets all criteria and has been approved by the AHRA, The Association for Medical Imaging Management for one (1) ARRT Category A CE Credit.

Radiology Administrator

This course meets all CRA criteria and has been approved by the AHRA, The Association for Medical Imaging Management for one (1) continuing education credit in the following CRA domain.

For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board or other credentialing organization.

Commercial Support

This program is supported by Guerbet, LLC.

ELUCIREM™ (gadopiclenol) injection Important Safety Information

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
ELUCIREM 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 ELUCIREM 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 for 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 ELUCIREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Indications and Usage

ELUCIREM™ (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

Contraindications

Contraindicated in patients with history of hypersensitivity reactions to ELUCIREM.

Warnings and Precautions

Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ELUCIREM have not been established with intrathecal use. ELUCIREM 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 ELUCIREM among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. Before ELUCIREM 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 ELUCIREM.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). 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. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent.
Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM.
Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI.

Adverse Reactions:

In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling.

Postmarketing Experience: Acute pancreatitis with onset within 48 hours after GBCA administration.

Use in Specific Populations

Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk.
Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age.
Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as NSF. No dose adjustment of ELUCIREM is recommended for patients with renal impairment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information, including the Medication Guide, for additional important safety information.

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