FDA Approves low dose gondolinium for Enhanced MRI Imaging in Adults and Children

The Food and Drug Administration (FDA) has approved low dose gondolinium Ambelvist® (gadoquatrane) for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates, to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS; brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system.

With this approval, AMBELVIST becomes the lowest-dose mGBCA in the U.S. AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight.

Why this approval matters:

Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions.3 For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required.

“I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.”

Key clinical trial findings:

The FDA approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of AMBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI.1 Key findings demonstrated:

• Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in AMBELVIST compared with only pre-contrast MRI images.

• Visualization scores and number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight (which delivers 0.04 mmol Gd/kg body weight) were similar to other tested mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight in descriptive analyses.1

• The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) have been established in pediatric patients, including term neonates. Use of AMBELVIST in this age group is supported by evidence from adequate and well-controlled studies of AMBELVIST in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region.1

AMBELVIST is associated with a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additionally, there are Warnings and Precautions related to hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization.