Radiology published a collaborative research road map regarding gadolinium retention and the safety of gadolinium-based contrast agents (GBCAs) in medical imaging on Sept. 11.
The special report was created by a group of international researchers, GBCA manufacturers and representatives of the FDA at a workshop co-sponsored by the National Institutes of Health (NIH), the Radiological Society of North America (RSNA) and the American College of Radiology (ACR) in February.
“It is our hope that this road map can serve to promote global, comprehensive collaborative research that effectively addresses the many important questions on the clinical significance of gadolinium retention in patients undergoing contrast-enhanced MRI examinations,” said co-author Herbert Kressel, MD, professor of radiology at Harvard Medical School, in a prepared statement. “Understanding the biologic changes due to the retention in these areas is essential in determining the clinical significance, if any, of gadolinium retention. "
The road map specifically highlights knowledge gaps in GBCA research, proposes solutions, identifies the feasibility and limitations of each approach and priority.
“The greatest priorities in GBCA research are to determine if gadolinium retention adversely affects the function of human tissues, if vulnerable populations such as children are at greater risk, and if retention is causally associated with short-term or long-term clinical manifestations,” according to the statement.
The authors—including experts in chemistry, measurement, clinical manifestations or health-related effects of retained gadolinium in human tissues—noted that eliminating these knowledge gaps will also require the standardization and validation of gadolinium and GBCA tissue measurement methods and quality assurance procedures.
Additionally, the authors advise that more large population databases should be studied to be analyzed which may help identify areas of concern that could be addressed in controlled research.
“Not yet known is the extent, mechanism, chemical form, and clinical implications of chronic gadolinium retention for each GBCA in the general population and in vulnerable populations, such as children and those with relevant comorbidities that may be at higher risk for potential retention,” the authors wrote. “These unknowns call for more systematic research and form the basis of this research roadmap to improve our understanding of gadolinium retention and its clinical importance.”