News | Contrast Media | January 30, 2018

Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Labeling for Pediatric MRI

FDA approves gadolinium-based contrast agent for MRI of the central nervous system in patients younger than 2 to visualize lesions with abnormal blood-brain barrier or abnormal vascularity

Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Approval for Pediatric MRI

January 30, 2018 — Bracco Diagnostics Inc. announced the labeling of its contrast agent MultiHance has obtained U.S. Food and Drug Administration (FDA) approval for an extension to include magnetic resonance imaging (MRI) of the central nervous system (CNS) in pediatric patients younger than 2 years of age (including term neonates). The agent may now be used in this patient population to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues.

The approval was based on data specifically obtained in pediatric patients younger than 2 years of age. Similar to older pediatric patients and adults, a dose of 0.1 mmol/kg was shown to significantly improve the visualization and morphologic assessment of CNS lesions. In neonates and infants, however, a dose of 0.05 mmol/kg is effective at improving the visualization of lesions in the brain and the spine. This provides healthcare professionals with dosing flexibility depending on patient and imaging conditions and needs.

MultiHance (gadobenate dimeglumine) injection, 529 mg/mL is a gadolinium-based contrast agent indicated for intravenous use in:

  • MRI of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues; and
  • Magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

Bracco noted that gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. The company counseled avoiding use of GBCAs 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 systemic fibrosis affecting the skin, muscle and internal organs.

Bracco noted the risk for NSF appears highest among patients with:

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

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

The company said that for patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

For more information: www.braccoimaging.com

Related Gadolinium Content

VIDEO: Big Concerns Remain for MRI Gadolinium Contrast Safety at RSNA 2017

VIDEO: How Serious is MRI Gadolinium Retention in the Brain and Body?

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents

Study Finds No Evidence that Gadolinium Causes Neurologic Harm

 

Related Content

Samsung Demonstrates Viability of Lower Dose Digital Radiography Algorithm for Pediatric Patients
News | Digital Radiography (DR) | April 24, 2019
Samsung announced that its new image post-processing engine (IPE), S-Vue 3.02, recently received U.S. Food and Drug...
ITN Wins Jesse H. Neal Award for Best Technical Content
News | Radiology Business | April 24, 2019
April 24, 2019 — Imaging Technology News (ITN) was recently named the 2019 Jesse H.
Artificial Intelligence Performs As Well As Experienced Radiologists in Detecting Prostate Cancer
News | Artificial Intelligence | April 18, 2019
University of California Los Angeles (UCLA) researchers have developed a new artificial intelligence (AI) system to...
A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images

A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images. The algorithm, described at the SBI/ACR Breast Imaging Symposium, used “Deep Learning,“ a form of machine learning, which is a type of artificial intelligence. Graphic courtesy of Sarah Eskreis-Winkler, M.D.

Feature | Artificial Intelligence | April 12, 2019 | By Greg Freiherr
The use of smart algorithms has the potential to make healthcare more efficient.
Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve