December 10, 2019 — 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). Full study results will be presented at the Radiological Society of North America (RSNA) Annual Meeting in December.
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, 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. 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 injection.
“We are pleased to share these innovative findings that not only help address an important question about gadolinium-based contrast agents, but also reinforce the results of the TRUTH study, which showed no significant difference in detection and characterization of central nervous system lesions with ProHance when compared to Gadavist7,” said Vittorio Puppo, President and CEO of Bracco Diagnostics Inc. “We believe the potential of cutting-edge technologies, like the ones developed by A.I. Analysis, Inc., will allow us continue to produce sophisticated research to help clinicians make optimal imaging decisions for their patients.”
About the Study
Each of the 32 patients with GBM in the study received both ProHance contrast and Gadavist contrast in a double-blind, randomized crossover technique. The images were evaluated in a blinded fashion using A.I. Analysis, Inc.’s Change Detector for Brain Imaging software, an advanced, layered machine-learning system. Enhancement characteristics for both agents were processed and the differences for each set of image pairs were calculated and analyzed. A 90 percent confidence interval of the mean of the difference in enhancement was calculated with a zone of equivalence defined to be from -0.2 to +0.2.
In the 27 patients that were evaluable, the Change Detector software found no statistically significant difference in enhancement characteristics between the standard concentration of ProHance contrast and the double concentration of Gadavist contrast. The p-value from paired t-test was p=0.3126. The Pearson correlation coefficient between the normalized ProHance contrast and Gadavist contrast was 0.958 (p<0.0001). For all 27 image pairs, the 90 percent confidence intervals were within the zone of equivalence.
“We are pleased at these results, and look forward to continued partnerships with global imaging leaders like Bracco to glean new insights that can help better inform the radiology community,” said Matthew J. Kuhn, M.D., chief medical officer at A.I. Analysis, Inc.
To learn more about ProHance contrast, visit www.prohanceperforms.com. To learn more about the Change Detector, visit www.aianalysis.com.
Related Content of MRI Gadolinium Safety Concerns
VIDEO: How Serious is MRI Gadolinium Retention in the Brain and Body? An interview with Max Wintermark, M.D.
VIDEO “Big Concerns Remain for MRI Gadolinium Contrast Safety at RSNA 2017,” An interview with Emanuel Kanal, M.D.
Radiology Has Failed to Properly Assess or Track MRI Gadolinium Contrast Safety
Recent Developments in Contrast Media
FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents
European Medicines Agency Issues Update on Gadolinium Contrast Agents
ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents
FDA: No Harm in MRI Gadolinium Retention in the Brain
April 18, 2024 
