WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer, a global leader in radiology, has initiated the Phase III clinical development program called QUANTI, aiming to evaluate the safety and efficacy of gadoquatrane, an investigational extracellular macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadoquatrane is a highly stable MRI contrast agent featuring high relaxivity being studied to evaluate the potential of a substantially lower gadolinium (Gd) dose for patients.1

The QUANTI clinical development program encompasses two large multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions), as well as one pediatric study, all investigating gadoquatrane at a dose of 0.04mmol Gd/kg body weight (bw). Thus, QUANTI development program investigates a gadolinium dose reduced by 60 percent compared to GBCAs dosed at 0.1mmol Gd/kg. The completion of a successful development program would demonstrate the lowest gadolinium dose for an MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method to obtain detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues to support physicians in answering critical medical questions in the diagnosis and monitoring of disease.2

“The demand for innovation in medical imaging to support diagnosis of diseases, guide treatment decisions and aid in therapy planning is growing as we see an increase in chronic diseases such as cancer and cardiac conditions,” said Prof. Michael Forsting, Director, Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Essen, Germany. “The Phase III clinical program QUANTI is an important step in establishing the safety and efficacy of an investigational agent dosed at a substantially lower gadolinium dose.”
“An estimated 13 million contrast-enhanced MRI procedures are performed annually in the United States to help inform doctors’ decisions and aid in providing diagnoses for patients.3 The broad development program of gadoquatrane underlines Bayer’s commitment as a leader in radiology to drive innovation for the benefit of patients and their treating physicians,” said Dr. Konstanze Diefenbach, Global Head of Radiology Research & Development, Bayer. “In addition to this potentially novel contrast agent gadoquatrane, Bayer has new automated injection systems and AI-enabled solutions.”

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