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A new study by Alwasiyah et al. concluded that the current reference range of 0.7 μg/24hr for 24-hour urinary gadolinium is not applicable to patients for at least 30 days following exposure to a gadolinium-based contrast agent (GBCA). In the study, the authors “calculated an estimated average of 57 days for the urinary gadolinium to creatinine ratio to reach below the current reference range following GBCA exposure and possibly much longer (i.e., 80+ days)”. The article, “Urinary Gadolinium Levels After Contrast-Enhanced MRI in Individuals with Normal Renal Function: a Pilot Study”, was published online December 12, 2018 in the Journal of Medical Toxicology.
This was a prospective, observational pilot study to determine urine gadolinium concentrations over a 30-day period after GBCA administration in patients with normal renal function. The 13 subjects were between 18 and 65 years of age and were reported to have received a gadolinium-based contrast agent for the first time. Prior to contrast administration, spot urine samples were obtained and tested for gadolinium and creatinine. All testing was performed by Mayo Medical Laboratories in Rochester, MN. Post-MRI 24-hour urine testing was performed on day 3, 10 and 30. Eight subjects received gadobutrol (Gadavist®), four received gadopentetate dimeglumine (Magnevist®), and 1 received gadoxetate disodium (Eovist®) for their MRIs with contrast. The authors reported that all 13 subjects had 24-hour gadolinium levels higher than 0.7 μg/24hr on day 3, day 10, and day 30 after contrast administration. The authors estimated that “urinary gadolinium levels will often remain above the current reference range for >50 days”. (more…)
Full-disclosure, we are reporting on our own retention paper.
Today we have released our fourth research paper on gadolinium retention from Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. The paper is titled “Gadolinium Retention from Contrast MRIs in 70 Cases with Normal Renal Function – 24-hour Urine Test Results”.
Drawing on the contrast MRI history and 24-hour gadolinium urine testing results information that we have received from members of the MRI-Gadolinium-Toxicity Support Group, we reported retrospectively on 70 cases with 120 urine test results. We are thankful to the members of our support group for being willing to share their information with us. The participants all had normal kidney function and report having symptoms of gadolinium toxicity. We believe the results reported are dramatic.
About the Gadolinium Retention Study
The number of results presented is up significantly from our last paper in 2014 when we reported on 15 cases and 40 test results. The additional data points allowed us to look at gender as a possible differentiator, but the data showed nearly identical test results for males and females. With information about the number of contrast-enhanced MRIs for each case, we were able to analyze the results in three groups: cases with a single contrast MRI, cases with 2 to 4 contrast MRIs, and cases with 5 or more contrast MRIs. Readers of this site will not be surprised that the analysis showed that for these cases, there was a discernible difference in test results based on these groupings. The 2 to 4 contrast group generally had higher levels of gadolinium in their urine for a longer period of time than those with a single contrast. Likewise, the results for the 5 or more MRIs group were higher longer than the cases in the 2-4 contrast MRIs group. This is consistent with the cumulative effect of multiple contrast-enhanced MRIs that others have reported.
We also provided the raw test results data for each case, enabling other researchers as well as patients to look at the progression of test results over time. Averages for time blocks since the last contrast MRI are also shown to help in understanding the progression of gadolinium urine levels.
A few observations regarding the test results are revealing. 21 cases had urine tests performed in the first month with results that range from 507 mcg Gd/24hr urine specimen 4 days after the contrast MRI to results around 17 mcg Gd/24hr near the end of the first month. All of the results are enumerated in the report. 8 cases had urine test results more than 36 months after their contrast MRI with results as high as 0.6 mcg Gd/24hr more than 7 years after the individual’s last contrast-enhanced MRI. There is no broadly utilized acceptable range for gadolinium in a 24-hour urine collection. Mayo Clinic has established a reference range that was recently updated to be 0.0-0.6 mcg Gd/24-hour urine specimen collected more than 96 hours after administration of a GBCA. 40 cases had urine tests in the first 3 months after their contrast MRI, with the lowest result being 1.74 mcg Gd/24hr, well above the Mayo reference range that is applicable once four days have elapsed since the contrast MRI. Simply stated the results we observed are inconsistent with the clearance times indicated on GBCA product labeling and the understanding of most researchers and clinical practitioners.
To the best of our knowledge, this is the most comprehensive reporting of retained gadolinium as evidenced by urine testing that is available to the public. While the methods we used do not meet the rigor of a clinical trial, and we do not know if similar results would be seen universally, we believe the consistency of the results and the lack of outliers on the low side are justification for concern. We believe that further investigation by researchers, GBCA manufacturers, and licensing agencies is warranted.
This study does not stand alone, but confirms the many recently published research papers that reported unexpected retention of gadolinium from contrast MRIs by people with normal renal function. We encourage stronger action by the FDA and others to inform patients about possible gadolinium retention from contrast-enhanced MRIs and the potential for long-term side-effects.
We urge patients, clinicians, and researchers to read the entire report and share as appropriate with your families, care-givers, and colleagues. Read the Report.
Hubbs Grimm and Sharon Williams
Suspecting or discovering that you are Gadolinium Toxic can be a scary time and you may not know what to do. And if you are like others, the journey to manage your condition will last for an extended period of time.
The 11 Tips we present here will make understanding and managing your condition an easier task. (more…)
While a test result of 36 mcg Gd/24-hours would be indeed one of the highest we have seen, it is not out of line with the other results reported on in the Retention Study. Look at the graphs and you will see that it is in line for tests in the 5 weeks after contrast infusion. The reason we may be surprised is that it is rare for someone to have a Urine test for Gd only a month after having the contrast MRI. The reason may be that the symptoms are slow to develop or just that they do not figure out the connection between the symptoms and the MRI for along time period.
The small number of test results that We have in that time frame are of roughly the same magnitude. And the other test results indicate that the number will come down very quickly. None of this means that the result of 36 mcg Gd/24-hours is not serious and high. It is, and the patient should take the action that they feel most comfortable with. Unfortunately there are no pat answers or we would not be still looking. The prime reason we collected and reported on the urine tests is so that we would have some factual test results by time-frame after the contrast MRI that people could compare with their results in their decision-making process.
To make this personal, I did not find out about my high Gd levels until 10 months after last contrast MRI and the result was about 1.0. I expect that I would have had a result at least as high as 36 if I had a urine test one month after the MRI.