Gadolinium Toxicity

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Study suggests Gadolinium Deposition in Dentate Nucleus with MultiHance – Patients had normal renal function

Another 2015 study in Radiology reports findings consistent with gadolinium deposition within the brains of patients with normal renal function (eGFR >60).  The study by Ramalho et al, High Signal Intensity in Globus Pallidus and Dentate Nucleus on Unenhanced T1-weighted MR Images: Evaluation of Two Linear Gadolinium-based Contrast Agents”, compared gadodiamide (Omniscan) and gadobenate dimeglumine (MultiHance).  The findings related to multiple administrations of gadodiamide are “in agreement with other investigators, who documented signal intensity changes associated with this contrast agent despite the presence of normal renal function”.  The authors also reported that, “A significant trend toward relative change in signal intensity was seen in the dentate nucleus (DN), but not in the globus pallidus (GP) after serial applications of gadobenate dimeglumine, suggesting that some gadolinium deposition also may occur with this agent”.

For the first time in the literature, the study established gadolinium accumulation related to the use of gadobenate dimeglumine, which is better known as MultiHance.  Of note is the fact that there are no unconfounded cases of NSF associated with the linear ionic gadolinium-based contrast agent (GBCA), MultiHance.  However, in this study, the patients in each group had received only one brand of GBCA.  Group 1 was comprised of 23 patients that had received between 3 and 11 doses of Omniscan, and Group 2 included 46 patients that had received between 3 and 11 doses of MultiHance.  All patients had normal liver and renal function.  (more…)

New MRI Safety Certification Exams cover long-term adverse effects of GBCAs

On June 24, 2015, the American Board of Magnetic Resonance Safety (ABMRS) administered exams, which will for the first time, certify Magnetic Resonance Medical Directors/Physicians (MRMD) and Magnetic Resonance Safety Officers (MRSO).  A third test, for Magnetic Resonance Safety Experts (MRSE), is expected to be ready for administration on or after the 4th quarter of 2015.

As we previously reported, the purpose of the ABMRS is to improve the safety of medical and research magnetic resonance (MR) environments.  That includes the safety of MR facilities and the certification and qualification of the professionals who oversee the physical and operational safety of the MR equipment, environment, and processes.

Dr. Emanuel Kanal, ABMRS Chairman, told us that he included in the examination content requirements that ABMRS certified MR practitioners be familiar with gadolinium based contrast agent safety issues – and that among the issues with which they want them to be familiar are long-term potential adverse effects of the administration of gadolinium-based contrast agents.   (more…)

Q&A with leading MRI Safety Expert Emanuel Kanal, MD

On May 5, 2015, Health Imaging published Q&A: Gadolinium update with leading MRI safety expert Emanuel Kanal, MD.  That same day, an editorial authored by Emanuel Kanal, MD, Director of MR Services at the University of Pittsburgh Medical Center, and Michael F. Tweedle, PhD, Professor and Stefanie Spielman Chair in Cancer Imaging at The Ohio State University Medical School, was published online in Radiology.  Their editorial, “Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients”, addresses the issue of gadolinium retention in patients with normal renal function.  The Q&A is a follow-up to that editorial.

For those who may not be familiar with Dr. ‘Manny’ Kanal, he is a nationally recognized radiologist and a leader in the area of MRI safety.  He is the Chair of the founding Board of Directors of the American Board of Magnetic Resonance Safety (ABMRS).  Dr. Kanal spoke with Health Imaging for an exclusive interview regarding the new evidence of gadolinium retention and its potential impact on diagnostic imaging and patient safety.

I will not go into all the details of the Q&A here, but there are several interesting comments that Dr. Kanal made that I want to mention.

Regarding the effects of retained gadolinium, Dr. Kanal questioned a comment in an article on Mayo Clinic News Network that was made by one of the authors of the recently published Mayo Clinic study.  He said something to the effect of ‘Well, no one has ever shown that this is harmful.’  Dr. Kanal, acknowledged that is true, but, he said, “At the same time, no one has ever studied it to date, so how could they show whether it’s harmful or not?”

When asked how many of the patients who received one or more of the estimated 10 million contrast injections in the U.S. each year could have retained gadolinium in their bodies, Dr. Kanal said, “There is the potential for some level of gadolinium retention for essentially 100 percent of those patients who receive contrast for an MR examination”. (more…)

Residual or Retained Gadolinium in Patients with Normal Renal Function – What happens next?

On May 5, 2015, an editorial by Emanuel Kanal, MD, Director of Magnetic Resonance Services and Professor of Radiology and Neuroradiology at the University of Pittsburgh Medical Center, and Michael F. Tweedle, PhD, Professor and Stefanie Spielman Chair in Cancer Imaging at The Ohio State University Medical School, was published online ahead of printThe editorial, “Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients”, is in the June 2015 issue of Radiology.  It addresses the issue of gadolinium retention in patients with normal renal function, as evidenced by published findings by Kanda et al, Errante et al, Quattrocchi et al, McDonald et al, and Radbruch et al.

In December of 2013, a study by Kanda et al first brought attention to what appeared to be evidence of residual gadolinium within the brain tissues of patients without severe renal disease.  The evidence of gadolinium in the brain started with reports of abnormal signals in the globus pallidus and the dentate nuclei on unenhanced T1-weighted MR images after repeated prior administration of certain gadolinium-based contrast agents or GBCAs.  Other studies found measureable concentrations of gadolinium in normal brain tissues from patients with normal renal (kidney) function.  In their editorial, Kanal and Tweedle said, “These provocative findings cause us to reconsider what we know and what we need to learn to better care for our patients”.

The authors said, “We now have clear evidence that the administration of various GBCAs results in notably varied levels of accumulation of residual gadolinium in the brain and bones of patients, even those with normal renal function.  What we still do not know is the clinical significance, if any, of this observation.” (more…)