Gadolinium-based contrast safe for vulnerable patients, new study says
After relaxing its protocols pertaining to the use of gadolinium-based contrast agents (GBCAs) in patients with acute or chronic renal failure, one healthcare system has good news to share about potential long-term risk.
Concerns over gadolinium retention and the onset of nephrogenic systemic fibrosis following GBCA administration have prompted organizations to develop protocols to protect patients who may be more vulnerable to renal damage. Prior data have connected GBCA use with such fibrosis, but more recent research indicates that the risk may be less concerning than previously believed.
“It became evident that certain GBCAs (i.e., group 1 agents according to the American College of Radiology) had a much stronger association with [nephrogenic systemic fibrosis] than others (i.e. group 2 or group 3 agents),” Daniel R. Ludwig, MD, with Washington University's Mallinckrodt Institute of Radiology, and colleagues noted. "More recent data showed that the risk of [fibrosis] with group 2 or 3 agents was low to nonexistent, even among patients with severe renal insufficiency or acute kidney injury," they added.
In 2020, ACR and the National Kidney Foundation published a joint statement stating that the potential harm of withholding group 1 or 2 GBCAs in patients with renal insufficiency or acute kidney injury likely outweighs the risk of fibrosis. In line with the NKF/ACR consensus statement, the Mallinckrodt updated its GBCA protocols to be more permissive in July 2023. Since then, it has tracked how often GBCAs are used in patients with acute kidney injury/dialysis and monitoring their health records to determine whether any went on to develop fibrosis.
Between July 1, 2023, and June 30, 2025, 2,911 (1.4% of all contrast-enhanced MRI orders) patients with acute kidney injury or on dialysis had requests entered for studies that would require gadolinium-based contrast. Of those, 1,440 (49.5%) were completed, while just over half (1,459) were canceled. Over a median follow-up period of 2 years, the team observed no instances of nephrogenic systemic fibrosis development in patients who received a GBCA during their exam, further supporting the use of these agents in patients previously faced restrictions.
“These results are consistent with prior studies showing a very low to nonexistent risk of [nephrogenic systemic fibrosis] in patients with acute or chronic renal failure receiving a group 2 or 3 GBCA,” the group concluded.
The push for lower dose GBCAs
These findings come amid ongoing efforts to reduce the amount of gadolinium in MRI contrast agents. Earlier this week, the U.S. Food and Drug Administration approved the lowest dose gadolinium-based contrast agent to date. Bayer’s Ambelvist, or gadoquatrane, is an intravenous macrocyclic GBCA indicated for contrast-enhanced MRI of the central nervous system and other non-CNS body regions in adults and children. Coming in at 0.04 mmol gadolinium per kilogram body weight, gadoquatrane has 20% less gadolinium than the lowest dose GBCA currently on the market.
Read more on the evolution of GBCAs below:
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.