Research & News

Keep abreast of radiology news and research on the MRI contrast agent safety and efficacy.

“Rat study finds no brain abnormalities from GBCAs”

Study published in Radiology by Smith APL et al, September 2016.

Researchers at GE Healthcare administered intravenous gadodiamide, gadopentetate dimeglumine, or saline solution to rats in low-dosage and high-dosage experimental groups for a period of five weeks. In follow-up measurements at one week and 20 weeks post-study, gadolinium levels in the blood and brains of rats had decreased to 0.00026% and .000001%, respectively. Neither histophathologic findings nor neurotoxicity were observed.

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“Study finds gadolinium hot spots, but no clinical effects”

Study published in Radiology by Prince MR et al, August 2016.

Researchers at Weill Cornell Medicine and Columbia University Medical Center reviewed the MRI images of 13 patients who received more than 35 gadolinium-based contrast agent administrations. Three radiologists conducted independent interpretations of brain images for each patient after six, 12, 24, and the last contrast agent administrations. They observed increased signal intensity in the dentate nucleus, globus pallidus, and substantia nigra in all participants’ brain images, and increased signal intensity in other areas in some participants’ brain images. However, no clinical effects were detected.

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“No link between gadolinium and parkinsonism”

Study published in JAMA by Welk B et al, July 2016.

In a 10-year retrospective study of 246,557 patients over 66 years old, researchers at Western University and the Institute for Clinical Evaluative Sciences in Canada investigated the outcome of primary parkinsonism diagnosis in patients who had had at least one MRI that was not of the brain or spine. When researchers compared patients who had gadolinium-enhanced MRI and non-gadolinium-enhanced MRI scans, they found no significant difference in the incidence of parkinsonism.

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“FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)”

Bulletin on FDA.gov, August 27, 2015.

The U.S. Food and Drug Administration (FDA) and its National Center for Toxicological Research (NCTR) study the potential risk of brain deposits of gadolinium-based contrast agents with multiple exposures to MRI scans with these agents, evaluating the mechanisms and potential health effects. While the data reviewed suggests that brain deposits can occur, with greater deposition in the case of linear agents and agents that are more prone to dissociation, no adverse health effects or pathological changes have been reported. In this bulletin, the FDA provide guidance to health professionals on using gadolinium-based MRI contrast agents and on reporting potential adverse effects.

FDA BULLETIN

“Intracranial gadolinium deposition after contrast-enhanced MR imaging”

Study published in Radiology by McDonald et al, June 2015.

Mayo Clinic neuropathologists performed brain autopsies on 13 deceased patients who had undergone at least four gadolinium-based contrast agent-enhanced MRI exams, and 10 deceased patients who had at least one unenhanced exam (and no enhanced exams). Patient MR images were also examined. In the images, repeated gadolinium-based contrast agent administrations were associated with increased signal intensity in the basal ganglia and posterior fossa, an effect that was not seen in gadolinium-unenhanced MRI group. Autopsies revealed detectable levels of gadolinium deposits in the neuronal tissues of deceased patients who had had gadolinium-enhanced MRI exams, but not in patients who had had unenhanced exams.

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“Long-term study confirms safety of gadolinium MRI contrast agent”

Study published in American Journal of Roentgenology by Fakhran et al, April 2015

Researchers at the University of Pittsburgh conducted a prospective study that included 132,252 gadobenate dimeglumine administrations over the course of 7.5 years in order to examine adverse reactions to this agent. In total, 236 adverse events were recorded. This proportion was not different from the ratio of adverse events to administrations for scans with other gadolinium-based contrast agents.

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“Study links gadolinium MR contrast to brain abnormalities”

Study published in Radiology by Kanda T et al, March 2014

Researchers at the Teikyo University School of Medicine in Tokyo, Japan, conducted a longitudinal analyses on patients’ MRI images, including 19 patients who had had six or more contrast-enhanced exams and 16 patients who had had six or more unenhanced exams. Signal intensity in the dentate nucleus and globus pallidus was significantly and directly correlated with the number of contrast administrations among patients who had had enhanced MRI exams, and hyperintensity was greater in patients who had had enhanced exams, compared with patients who had had unenhanced exams.

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