Abstract

Patients with multiple sclerosis routinely have MR imaging with contrast every 6-12 months to assess response to medication. Multiple recent studies provide evidence of tissue deposition of MR imaging contrast agents, questioning the long-term safety of these agents. The goal of this retrospective image-analysis study was to determine whether contrast could be reserved for only those patients who show new MS lesions on follow-up examinations. We retrospectively reviewed brain MRIs of 138 patients. To increase our sensitivity, we used a previously described computerized image-comparison software to evaluate the stability or progression of multiple sclerosis white matter lesions in noncontrast FLAIR sequences. We correlated these findings with evidence of contrast-enhancing lesions on the enhanced T1 sequence from the same scan. Thirty-three scans showed an increase in white matter lesion burden. Among those 33 patients, 14 examinations also demonstrated enhancing new lesions. While we found a single example of enhancement of a pre-existing white matter lesion that appeared unchanged in size, that same examination showed an overall increase in lesion burden with enhancement of other, new lesions. Thus, we found that all patients with enhancing lesions had evidence of progression on their noncontrast imaging. Because all enhancing lesions were associated with new lesions on unenhanced imaging and progression was only evident in 24% of patients, in patients with relapsing-remitting MS, it is reasonable to consider reserving contrast for only those patients with evidence of progression on noncontrast MR images.

Highlights

  • BACKGROUND AND PURPOSEPatients with multiple sclerosis routinely have MR imaging with contrast every 6 –12 months to assess response to medication

  • While we found a single example of enhancement of a pre-existing white matter lesion that appeared unchanged in size, that same examination showed an overall increase in lesion burden with enhancement of other, new lesions

  • Because all enhancing lesions were associated with new lesions on unenhanced imaging and progression was only evident in 24% of patients, in patients with relapsing-remitting MS, it is reasonable to consider reserving contrast for only those patients with evidence of progression on noncontrast MR images

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Summary

MATERIALS AND METHODS

After receiving institutional review board approval for the study, a list of 197 sequential, unique identifying numbers of follow-up brain MR images was generated from September 19, 2017, to October 31, 2017. The software is routinely run by our departmental 3D lab, and this program sends the DICOM image files directly back to the PACS While this program has not received a formal FDA certification, the paired, matching source multiplanar reformats from each of the 3D-FLAIR scans are available to imagers at the time of interpretation along with the computer-processed composite images indicating change. The composite images of the remaining 140 patients were reviewed independently by 2 investigators to determine the lesion burden of white matter lesions on the most recent scan compared with the prior one. This was characterized in terms of increase, decrease, or stability on the basis of the nonenhanced FLAIR sequence, often supported by proton-density sequences. In the 1 instance of enhancement of a pre-existing lesion, no specific phenotype of MS was indicated in the clinical history

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34. FDA Drug Safety Communication
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