Artificial intelligence software confirms the results of a large scale comparison of ProHance (Gadoteridol) Injection, 279.3 mg/mL and Gadavist (gadobutrol) Injection in MRI of the brain (the TRUTH study)

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced the results of an experimental artificial intelligence (AI) study of two gadolinium-based contrast agents (GBCAs) which found that ProHance (Gadoteridol) Injection, 279.3 mg/mL and Gadavist provided similar degree and pattern of contrast enhancement in brain magnetic resonance imaging (MRI) of patients with glioblastoma multiforme (GBM) previously enrolled in a large scale, multicenter, randomized, double blinded controlled clinical study (the TRUTH study).1 Full study results will be presented at the Radiological Society of North America (RSNA) Annual Meeting on Wednesday, December 4, in Chicago, IL. GBCAs are widely used imaging agents with a favorable safety profile. While recent research has shown that the gadolinium from these agents may remain in the body for months to years after injection,2 the American College of Radiology and the Food and Drug Administration agree that there are no known adverse clinical consequences associated with gadolinium retention in the brain based on the available data.3,4 Nevertheless, some practitioners have concerns, and questions have been raised over whether using a GBCA that retains less would come with a tradeoff in the effectiveness of the contrast enhancement. The purpose of this study was to use AI to determine the effectiveness of standard concentration ProHance (0.5mmol/ml) compared to double concentration Gadavist (1.0 mmol/ml), since animal studies have shown that Gadavist retains two to seven times more in the brain versus ProHance, at up to 4 weeks after injection5-6.