- Gadoquatrane is a highly stable contrast agent for magnetic resonance imaging (MRI) featuring high relaxivity with the potential for a substantially lower gadolinium (Gd) dose
- QUANTI clinical development program includes two Phase III studies in adults and one pediatric study investigating gadoquatrane for use in MRI across all body regions and all ages
- As a leader in radiology, Bayer is advancing innovation in medical imaging
Bayer has started the Phase III clinical development program QUANTI, aiming to evaluate the efficacy and safety of gadoquatrane, a next-generation, 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 that has the potential to enable a substantially lower gadolinium (Gd) dose for patients, the German company announced in a communiqué on June 27th.
The QUANTI clinical development program encompasses two 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 0.04 mmol Gd/kg body weight (bw). This represents a gadolinium dose reduced by 60 percent in contrast-enhanced MRI compared to standard dosing of established products, which, if successfully tested, would constitute the lowest gadolinium dose for a multipurpose MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method of obtaining detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues and supporting physicians in answering critical medical questions in the detection, characterization, and monitoring of disease.
“The demand for innovation in medical imaging to detect diseases, guide treatment decisions, and aid in therapy planning is growing as we see an increase in chronic diseases such as cancer and cardiovascular conditions,” said Prof. Michael Forsting, Director, Institute of Diagnostic and Interventional Radiology and Neuroradiology, University of Essen, Germany. “The QUANTI Phase III clinical program is an important step in evaluating a new option for substantially lowering the gadolinium dose while maintaining image quality, supporting accurate and timely diagnosis.”
“An estimated 59 million contrast-enhanced MRI procedures are performed annually worldwide to support doctors in accurate diagnoses for patients.1 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. “With gadoquatrane, we strive to advance innovation in medical imaging, including novel contrast agents, as well as 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 0.04 mmol 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 in 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 of all ages 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 study demonstrating the efficacy of gadoquatrane with a favorable safety profile at a dose of 0.04 mmol 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.
Gadoquatrane is Bayer’s next-generation extracellular contrast agent in clinical development for contrast enhancement in MRI. This novel, macrocyclic, gadolinium-based contrast agent features 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. It might also lead to long-term sustainable patient care, as gadolinium is a rare earth element that is not found in its pure form in nature and complex to separate.2
1 – Based on internal and external data such as IQVIA, Contrast Media Industry Group and Clarivate
2 – Gadolinium (Gd). By: Podeszwa, Catherine, MS, Salem Press Encyclopedia of Science, 2021; The Institute for Rare Earths and Metals: https://en.institut-seltene-erden.de/seltene-erden-und-metalle/seltene-erden/gadolinium/