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MultiHance found to leave residual gadolinium in the brain
A new study by Weberling et al, Increased Signal Intensity in the Dentate Nucleus on Unenhanced T1-Weighted Images after Gadobenate Dimeglumine Administration, found increased signal intensity (SI) in the dentate nucleus (DN) after serial injections of the linear gadolinium-based contrast agent (GBCA) gadobenate dimeglumine (MultiHance, Bracco Diagnostics Inc.). The study included 50 patients that had a minimum of 5 consecutive brain MRI scans with MultiHance. All MRIs were performed between March 1, 2014 and December 31, 2014 in the German Cancer Research Center, Heidelberg, Germany. 45 of the patients had an estimated glomerular filtration rate (eGFR) greater than 60, and 5 had an eGFR between 45 and 60.
Like the 2015 study by Radbruch et al, the exclusion criteria included: history of brain hemorrhage, stroke, or brain ischemia; edema, tumor, or other lesions located in the cerebellum or pons; history of intracranial infection, such as meningitis or encephalitis; missing or unsatisfactory unenhanced T1-weighted MRI scans; and missing documentation of the contrast agent administered.
The study found an increased SI in the DN-to-CSF (cerebrospinal fluid) and DN-to-pons ratios on unenhanced T1-weighted images in patients that had at least 5 MRIs with the gadolinium-based contrast agent MultiHance. The authors said, “Because the previous work by McDonald et al showed that SI correlates with gadolinium retention in the respective area, the SI increase found herein likely reflects the specific potential of gadobenate dimeglumine to release gadolinium”. (more…)
Radiologists are in best position to watch patients’ backs
An August 1, 2015 article by Richard Dargan, Radiology Society of North America (RSNA), reviewed recent studies that reported finding evidence of gadolinium retention in the brains of patients with normal renal function. The article, “Radiology Should Take Lead in MRI Contrast Media Use, Research”, also included comments from Emanuel Kanal, M.D., regarding the role radiologists should play in MRI contrast agent research and usage. Dr. Kanal, a Professor of Radiology at the University of Pittsburgh Medical Center (UPMC), chairman of the American College of Radiology MR Safety Committee from 2002-2012, and chairman of the new American Board of Magnetic Resonance Safety (ABMRS), made his comments in an interview with RSNA News.
Recent research has shown that gadolinium-based-contrast agents (GBCAs) are leaving residual gadolinium in the brains of patients, including patients with normal renal function. Two regions in particular have been affected: the dentate nucleus and the globus pallidus. A 2013 study by Kanda et al, first reported finding high signal intensity in those two brain regions on unenhanced T1-weighted magnetic resonance (MR) images that appeared to be related to the increasing cumulative dose of a gadolinium-based contrast agent. Since then, additional studies have been published which confirmed the increased signal intensity is the result of gadolinium accumulation within the brain. (more…)
FDA action is urgently needed on MRI contrast agent safety issues
Editorial – I believe the FDA needs to do more to regulate the use of linear and macrocyclic gadolinium-based contrast agents administered for enhanced MRIs and MRAs.
Since January 2014, I am aware of nine studies that have reported finding evidence of gadolinium deposition within the brain tissues of patients exposed to gadolinium-based contrast agents or GBCAs. In most of those studies, the patients did not have severe renal disease, in fact, most were described as having “normal renal function” or an eGFR >60. Despite the increasing number of new studies that indicate that gadolinium is remaining in the brain, some still question whether there is any clinical significance. Speaking as someone who has been adversely affected by retained gadolinium, I believe that there is clinical significance, and I am not alone. Members of our MRI-Gadolinium-Toxicity support group have reported symptoms that are consistent with what is known about the toxic effects of gadolinium. Since we released the results of our 2014 Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs, our support group has almost tripled in size and another affected patient recently started a group on Facebook. I believe the problems related to gadolinium retention are significant, but they are not being recognized. (more…)
Study reports Increasing Signal Intensity within the Brains of Patients with Multiple Sclerosis after multiple injections of the macrocyclic GBCA Gadovist – All Patients had Normal Renal Function
On June 25, 2015, European Radiology published a new study online ahead of print that reports increasing signal intensity on brain MR images after repeated administrations of the macrocyclic agent, gadobutrol (Gadovist, Bayer Healthcare, Berlin, Germany). The study by Stojanov et al is titled, Increasing signal intensity within the dentate nucleus and globus pallidus on unenhanced T1W magnetic resonance images in patients with relapsing-remitting multiple sclerosis: correlation with cumulative dose of a macrocyclic gadolinium-based contrast agent, gadobutrol. This is the first study to report a correlation between the cumulative dose of a macrocyclic, gadolinium-based contrast agent (GBCA), and gadolinium deposition within the dentate nucleus (DN) and globus pallidus (GP) in patients with relapsing-remitting multiple sclerosis (RRMS). All patients had normal renal function at the beginning and end of the study.
Liver function was also normal at the beginning of the study; however, the authors noted that at the end of the study there was a significant increase (p=0.004) in GGT, gamma-glutamyl transpeptidase. The other liver function parameters remained normal.
Since all patients had normal renal function at the beginning and end of the study, there was no correlation between renal function and signal intensity within either dentate nucleus or globus pallidus. The authors noted that, “This suggests that gadolinium deposition within the brain may occur even in patients with normal renal function”. (more…)
Gadolinium Toxicity 