Bayer initiates Phase III Studies with Investigational Contrast Agent Gadoquatrane

July 7, 2023 — 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.” 

About the Phase III development program for gadoquatrane 

The QUANTI clinical development program consists of two large multinational Phase III studies, QUANTI CNS and QUANTI OBR in adults, as well as one pediatric study, investigating gadoquatrane at a dose of 0.04mmol Gd/kg bw. 

QUANTI CNS evaluates the efficacy and safety of gadoquatrane in adults with known or highly suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI. Common CNS diseases are for example benign or malignant brain tumors and multiple sclerosis, where MRI plays a key role along diagnosis and treatment decisions. 

QUANTI OBR investigates the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, such as head and neck, thorax, abdomen, pelvis, and extremities. The pediatric study assesses the pharmacokinetics and safety of gadoquatrane in children aged 0-18 years undergoing contrast-enhanced MRI. In total, the QUANTI clinical development program intends to enroll approximately 800 patients in 17 countries. 

The design and dosing of the Phase III clinical development program is based on the positive data from the Phase II safety and efficacy study, with a dose of 0.04mmol Gd/kg body weight. The Phase II study was a multicenter, single-blind, adaptive dose-finding study of single intravenous injections of gadoquatrane with corresponding blinded read in adult participants with known or highly suspected CNS lesions referred for contrast-enhanced MRI. 

About gadoquatrane 

Gadoquatrane is an investigational extracellular contrast agent in clinical development for contrast enhancement in MRI. This potentially novel, macrocyclic gadolinium-based contrast agent has a distinct tetrameric structure with high stability and high relaxivity, which has the potential to enable a lower clinical gadolinium dose in contrast-enhanced MRI for patients. 

For more information: www.bayer.com 

References 

1 Lohrke J, Berger M, Frenzel T, Hilger CS, Jost G, Panknin O, Bauser M, Ebert W, Pietsch H. Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. Invest Radiol. 2022 Oct 1;57(10):629-638. doi: 10.1097/RLI.0000000000000889. Epub 2022 Jun 13. PMID: 35703267; PMCID: PMC9444293.

2 National Institute of Biomedical Imaging and Bioengineering. Magnetic Resonance Imaging (MRI). Retrieved June 12, 2023 from: https://www.nibib.nih.gov/science-education/science-topics/magnetic-resonance-imaging-mri.

3 Arlington Medical Resources. (2021). The Imaging Market Guide - United Stated Edition, July 201 – December 2021. Burlington, MA: Clarivate | Decision Resources Group. 

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