News | Contrast Media | December 10, 2019

AI Software Confirms the Results of a Large Scale Comparison of Gadoteridol and Gadavist Injection

Results were presented at RSNA19 for the comparison of ProHance (Gadoteridol) Injection, 279.3 mg/mL and Gadavist (gadobutrol) Injection in MRI of the brain (the TRUTH study)

 

Results were presented at RSNA19 for the comparison of ProHance (Gadoteridol) Injection, 279.3 mg/mL and Gadavist (gadobutrol) Injection in MRI of the brain (the TRUTH study)

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

VIDEO: MRI Gadolinium Contrast Retention in the Brain

Gadolinium May Remain in Brain After Contrast MRI

Related Content

Important milestone demonstrates the unrivalled experience, technological innovation and global market leadership of IBA and its clinical partners
News | Proton Therapy | September 25, 2020
September 25, 2020 — IBA (Ion Beam Applications SA) announced that more than 100,000 patients have now been treated w
Philips Azurion Lung Edition supports high precision diagnosis and minimally invasive therapy in one room
News | Lung Imaging | September 21, 2020
September 21, 2020 — Philips introduced...
Final rule includes mandatory participation for nearly 1,000 practices and does not allow sufficient time for transition

Getty Images

News | Radiation Oncology | September 21, 2020
September 21, 2020 — In response to the September 18 ...
According to a new report published by P&S Intelligence, the global radiotherapy market is expected to expand from $7.2M in 2019 to $17M by 2030.

Image courtesy of Accuray

Feature | Radiation Therapy | September 21, 2020 | By Melinda Taschetta-Millane
According to a...
A new report, Magnetic Resonance Imaging Equipment Market Size, Share & Industry Analysis, conducted by Fortune Business Insights, states that the magnetic resonance imaging (MRI) equipment market reached $7.24 billion in 2019 and is projected to reach $11.36 billion by 2027

Image courtesy of Siemens Healthineers

Feature | Magnetic Resonance Imaging (MRI) | September 21, 2020 | By Melinda Taschetta-Millane
A new report,...
Breast cancer patients whose disease has spread to their brains fare better if their metastases are picked up before they begin to cause symptoms, according to a study presented at the 12th European Breast Cancer Conference.

Getty Images

News | Breast Imaging | September 21, 2020
September 21, 2020 — Breast cancer patients whose disease has spread to their brains fare better if their metastases
Of all the buzzwords one would have guessed would dominate 2020, few expected it to be “virtual”. We have been virtualizing various aspects of our lives for many years, but the circumstances of this one has moved almost all of our lives into the virtual realm.

Getty Images

Feature | Radiology Education | September 18, 2020 | By Jef Williams
Of all the buzzwords one would have guessed would dominate 2020, few expected it to be “virtual”.
Data from latest research presented at the ESMO Virtual Congress 2020 suggests COVID-19 pandemic halts cancer care and damages oncologists' wellbeing

Getty Images

News | Coronavirus (COVID-19) | September 17, 2020
September 17, 2020 — Delays and cancellation of cancer treatments and other safety measures undertaken to minimize th