A young man with cystic fibrosis (CF) has become the first patient in the U.S. to undergo MRI lung imaging combined with Xenoview, a novel technology by Polarean Imaging for visualizing lung ventilation.
The scan, done in a 19-year-old CF patient, took place at the Cincinnati Children’s Hospital Medical Center, in Ohio, which expects to adopt more regular use of the technology in a larger group of its patients.
Xenoview is the only imaging agent of its kind to be approved by the U.S. Food and Drug Administration (FDA). It is cleared for use with MRI in children and adults, ages 12 and older, as a way of evaluating lung ventilation.
“The first clinical scan in the United States is a significant milestone for Polarean and the XENOVIEW technology,” Hullihen said, adding, “We are in discussions with numerous other medical centers about the adoption of this novel technology and expect this ability to view lung ventilation more fully will be available at additional hospitals in the coming months.”
Xenoview approved in US late last year
More than 37 million Americans live with a chronic lung disease such as cystic fibrosis. A number of lung imaging approaches exist to monitor these patients and track lung damage — each with their own advantages and disadvantages, according to Polarean.
But while some techniques are able to identify airway structure, none are very effective at visualizing functional ventilation status, or how effectively gas is being exchanged in the lungs.
Also, some approaches require radiation, which can introduce a safety risk for patients undergoing the procedure.
Xenoview was designed to enable physicians to visualize ventilatory function without the need for radiation when coupled with MRI imaging.
In this approach, an inert gas called xenon is sent through a specialized device called the Polarean HPX Hyperpolarisation System. With it, the gas is hyperpolarized, a state that gives it the capacity to enhance the MRI signal.
Participants are then asked to inhale the hyperpolarized gas and hold their breath for 1o-15 seconds while in the MRI scanner. The gas is then distributed in the lungs in the same way regular air would be.
The resulting images provide doctors with a map of a person’s ventilation status that can be used to inform the management of their disease.
Being able to use this technology for the evaluation of ventilation in the clinic, including on patients as young as 12 years old, increases the population of people that could benefit from this revolutionary imaging technology.
The technology was approved by the FDA in December, making it the first U.S.-approved hyperpolarized contrast agent for MRI.
The approval was backed by two open-label Phase 3 trials (NCT03418090 and NCT03417687) in patients being evaluated for possible lung resection (tissue removal) or transplant. Both trials met their primary efficacy goals of determining predicted lung function.
“I am thrilled to be extending Xenoview from research to the clinical setting so that we can serve more patients in need at our hospital,” said Jason Woods, PhD, director of research in pulmonary medicine at Cincinnati Children’s.
“Being able to use this technology for the evaluation of ventilation in the clinic, including on patients as young as 12 years old, increases the population of people that could benefit from this revolutionary imaging technology,” Woods added.
Ongoing research is being conducted to expand the applications for Xenoview, according to the company.