Guerbet's Elucirem macrocyclic gadolinium-based contrast agent (GBCA) has been classified as a group II agent by the American College of Radiology (ACR).
Elucirem is used in MRI exams to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). It was designed to require only half the dose of conventional GBCAs, the manufacturer said.
The group II classification by ACR means that the risk of patients experiencing nephrogenic systemic fibrosis (hardening of the skin and subcutaneous tissues) -- a known side effect of GBCAs -- is estimated to be very low, the company said.
Guerbet received U.S. approval of Elucirem (gadopiclenol) in September 2022. Gadopiclenol was co-developed with Bracco, which launched its commercial version of gadopiclenol, Vueway, also last year.
