To date, researchers have been unable to find any evidence of neurological damage or other adverse effects relating to the found gadolinium retention in the brain, but there is a renewed effort in the industry to investigate the issue. Meanwhile, some researchers are investigating alternative methods for creating readable MR scans using alternative contrast agents or no agents at all.

A recent Ph.D. graduate from Stanford, Enhao Gong and Dr. Greg Zaharchuk from Radiology at Stanford, founded a startup called Subtle Medical Inc., which is developing an AI solution from technology validated at Stanford that aims to cut the gadolinium dose to 10 percent during MR exams.


“We are getting more transparent about gadolinium, and whether or not we want to use it,” said Dr. Gong. “With AI, you can enhance the quality of the image so that 10 percent dosage is the same as 100 percent dosage. We can train software to read images better than the human eye, so that means we need less contrast.”

Changes are also taking place on regulatory levels, with the FDA recently issuing a requirement for manufacturers to include gadolinium retention label warnings for GBCAs to relay information on gadolinium remaining in the bodies of patients, including the brain, for months to years after.

The decision followed an extensive review and talks with the Medical Imaging Drugs Advisory Committee, though no adverse health impacts were found in its investigation. In addition, the agency will also require manufacturers to conduct additional studies on animals and will conduct a study on patients who undergo repeat GBCA MR screenings to investigate the possibility of neurologic effects.

A new perspective on implants and MR
Like gadolinium, safety concerns have also surrounded the compatibility of implants in MR environments, with many radiologists hesitant to perform scans on patients with implants lacking MR-conditional labeling. While proven relatively safe in numerous studies, it was not until the decision this spring by the Centers for Medicare and Medicaid Services to cover such devices, that many began to warm up to the idea.

“When MR conditional devices that were labeled by the FDA first came out, they were tested and designed to indicate that under certain specified conditions, they would be safe when subjected to MR so that patients with those devices could be scanned,” said Dr. Henry Halperin, professor of medicine, radiology and biomedical engineering at Johns Hopkins University. “For devices that were not specifically designed to be MR-conditional, the presumption was that that they were not safe, although there were small amounts of data to suggest that it was okay.”

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