Bayer announces positive pediatric trial results for gadoquatrane

At RSNA 2025 today, Bayer announced positive results from the QUANTI Pediatric Study clinical trial (NCT05915026) evaluating the pharmacokinetic, safety, and efficacy of the investigational low-dose MRI gadolinium-based contrast agent gadoquatrane in children.

The findings of the multinational, multicenter, prospective open-label study showed that pediatric patients had similar pharmacokinetic behavior as the adults who participated in two similar phase III clinical trials, the QUANTI CNS and the QUANTI OBR. Ninety-three children ranging from newborn to 18 years old with suspected or known disease and undergoing MRI received a dose of 0.4 mmol Gd/kg body weight, a 60% lower dose than if macrocyclic gadolinium-based contrast agent had been used.

Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent for contrast enhancement in MRI. It features a distinct tetrameric structure with high stability and high relaxivity.

The results of the three QUANTI studies show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. The observed safety profile was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs, Bayer reported.