News | July 07, 2008

FDA Approves MRI Contrast Agent for Liver Cancer

July 8, 2008 – The FDA approved Bayer HealthCare Pharmaceuticals’s EOVIST (Gadoxetate Disodium) Injection, a gadolinium-based contrast agent, for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

The approval makes EOVIST the first organ-specific MRI contrast agent approved in the U.S. in more than a decade. EOVIST is a paramagnetic MRI contrast agent that combines features of both an extracellular contrast agent and a hepatocyte-specific agent. EOVIST is administered via an intravenous, bolus injection and has a dual route of excretion with approximately 50 percent eliminated through the liver and 50 percent eliminated through the kidney. Detection and characterization of malignant and benign focal liver lesions with EOVIST may help enhance diagnostic accuracy and increase diagnostic confidence.

“EOVIST-enhanced images can provide more comprehensive information about focal liver lesions in a single, short imaging session than was previously available,” said Jeffrey Brown, M.D., professor of radiology, Washington University School of Medicine, St. Louis. “With the availability of EOVIST, our ability to evaluate patients with benign and malignant focal hepatic lesions will be improved.”

Eight-hundred sixteen (816) patients with suspected or known focal liver lesions were enrolled in two of four non-randomized, intrapatient-controlled studies that evaluated predominantly the detection (Studies one and two) or morphological characterization (Studies three and four) of liver lesions. Studies one and two (“detection” studies) enrolled patients who were scheduled for liver surgery. MRI results were compared to a reference standard that consisted of surgical histopathology and the results from intra-operative ultrasound of the liver. The studies assessed the sensitivity of pre-contrast MRI and EOVIST-contrasted MRI for the detection of liver lesions when each set of images was compared to the reference.

Studies three and four (“characterization” studies) enrolled patients with known or suspected focal liver lesions, including patients who were not scheduled for liver surgery. MRI results were compared to a reference standard that consisted of surgical histopathology and other prospectively defined criteria. The studies assessed the correctness of liver lesion characterization by pre-contrast MRI and EOVIST-contrasted MRI when each set of images was compared to the reference. Lesions were characterized as one of the following choices: hepatocellular carcinoma, cholangiocarcinoma, metastasis, focal lymphoma, adenoma, focal nodular hyperplasia, hemangioma, abscess, focal liver fibrosis, regenerative nodule, focal fat, hydatid cyst, liver cyst, “not assessable,” normal, no lesion or “other.”

In all four studies, patients underwent a baseline, pre-contrast MRI followed by the administration of EOVIST at a dose of 0.025 mmol/kg body weight, with MRI performed immediately (the “dynamic” phase) and at 10 to 20 minutes following EOVIST administration (the “hepatocyte” phase). Patients also underwent computerized tomography with contrast examinations of the liver. Precontrast MRI and EOVIST-contrasted MR images were evaluated in a systematic, randomized, paired and unpaired fashion by three radiologists who were blinded to clinical information. Computed tomography (CT) images were also evaluated by the radiologists in a separate reading session.

EOVIST was generally well-tolerated during the trials. The safety database was based on EOVIST exposure in 1,755 adult subjects who received a dose that ranged from 0.003 to 0.5 mmol/kg body weight; the majority (N=1,365) received the recommended dose of 0.025 mmol/kg body weight.

Overall, 4.3 percent of subjects reported one or more drug-related adverse reactions during a follow-up period that, for most subjects, extended more than 24 hours after EOVIST administration. These adverse reactions were predominantly of mild to moderate severity. Serious adverse events were reported among six patients and were attributed to underlying conditions or non-MRI procedures. All serious events occurred more than 10 hours following EOVIST administration. The most common adverse reactions at the recommended dose were feeling hot, nausea, headache, injection site reaction (pain, burning, coldness, extravasation), dysgeusia (taste abnormality), flushing, parosmia (smell abnormality), dizziness and vomiting.

For more information: www.Imaging.BayerHealthCare.com

Related Content

Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
OptiStar Elite injector
Feature | Contrast Media Injectors | March 07, 2018 | Grand View Research Inc.
The global contrast media injectors market is expected to reach $1.4 billion by 2025, growing at a compound annual...
TriHealth in Cincinnati

TriHealth in Cincinnati.

Sponsored Content | Case Study | Contrast Media Injectors | March 06, 2018
The continuing search for advantages to improve workflow has radiology departments constantly searching for new...
Guerbet Presents Contrast&Care Injection Management Solution at ECR 2018
News | Contrast Media | February 28, 2018
February 28, 2018 — Guerbet will present its new Contrast&Care application, as well as other...
A brain MRI. Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns. Gadolinium deposition in the brain has raised concerns about Gadolinium toxicity.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Feature | Magnetic Resonance Imaging (MRI) | February 16, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
ACR Introduces New Contrast Reaction Card
News | Contrast Media | February 07, 2018
The American College of Radiology (ACR) introduced a new contrast reaction card that summarizes important steps to be...
Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Approval for Pediatric MRI
News | Contrast Media | January 30, 2018
Bracco Diagnostics Inc. announced the labeling of its contrast agent MultiHance has obtained U.S. Food and Drug...
Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Overlay Init