Gadopiclenol in MRI diagnosis: A systematic review of its efficacy and safety

Background and Purpose: Gadolinium-based contrast agents (GBCAs) are critical in the detection and characterization of lesions. However, safety concerns for standard-dose GBCAs, related to hypersensitivity and non-hypersensitivity (chemo/osmotoxic) reactions, necessitate safer alternatives. Gadopiclenol, a novel high-relaxivity macrocyclic GBCA, may enable dose reduction without compromising diagnostic efficacy. This systematic review aimed to compare Gadopiclenol's safety and efficacy to standard-dose GBCAs. Materials and Methods: A systematic search of PubMed, Embase, CENTRAL, ICTRP and Clinicaltrials.gov was conducted, without language restrictions. Studies were included if they evaluated Gadopiclenol's safety and efficacy in MRI; non-human studies were excluded, with the risk of bias assessed using ROB-2 and ROBINS-I. Results and Conclusion: Our search strategy yielded 155 records, of which ten trials qualified for qualitative synthesis. These included 1121 subjects, 129 healthy volunteers, and 992 patients with pathology, using both 1.5T and 3T MRI systems. Efficacy was evaluated in six studies. At a 0.05 mmol/kg dose, Gadopiclenol consistently met or surpassed non-inferiority margins compared to traditional GBCAs at 0.10 mmol/kg for lesion border delineation, internal morphology, and contrast enhancement (P < 0.0001). Quantitative metrics also favored Gadopiclenol. Safety was assessed in nine studies, with a comparable incidence of adverse events reported when compared to traditional GBCAs.