FDA Approves Xenoview for Use with MRI for the Evaluation of Lung Ventilation

In the early 1990s, the field of hyperpolarized gas Magnetic Resonance Imaging (MRI) was introduced via the use of the isotope xenon 129 (129Xe).1

However, the relatively low available 129Xe polarization (1%–2%) generated less than optimal image quality which inevitably petered out enthusiasm for its use. In the last decade, progress in 129Xe polarization technology has led to a resurgence of interest and the reintroduction of 129Xe MRI in humans with promising results.2,3

In December 2022, Polaren Imaging’s Xenoview™, a hyperpolarized contrast agent prepared from a proprietary Xenon 129Xe Gas Blend, received FDA approval for use with MRI for evaluation of lung ventilation in adults and paediatric patients aged 12 years and older.4 Xenoview is produced on-site by the HPX Hyperpolarization System from an isotopically enriched Xenon 129Xe Gas Blend. The blend contains xenon (1% total:>80% isotopic purity 129Xe), nitrogen, NF (10%) and helium, NF (89%). It is a clear, colourless, odourless gas contained in a 1000mL Xenoview Dose Delivery Bag. The bag contains at least 75mL Dose Equivalent of hyperpolarized xenon 129Xe in a volume of 250mL to 750mL total xenon. The product is administered by oral inhalation as a single 10-15 second breath hold MRI procedure. Xenoview provides a powerful novel visualization tool for physicians which does not expose patients to any ionizing radiation and its associated risks. Notably, the FDA also granted simultaneous approval to Xenoview VDP, an image analysis platform, and Xenoview 3.0T Chest Coil, to be used in conjunction with compatible MRI scanners and Xenoview for the visualization and quantification of regional lung function.

FDA approval of Xenoview was based on data from two prospective multicenter randomized, open-label, cross-over trials comparing MRI with 129Xe gas, polarised in Polarean’s system, to 133Xe scintigraphy. The studies enrolled a total of 83 adult patients with various lung disorders who were being evaluated for possible lung surgery. The mean Xenoview dose used in these trials was 99 mL Dose Equivalent (DE) of hyperpolarized xenon 129Xe at the time of measurement within 5 minutes of administration. Both clinical trials met their primary endpoints, within the prospectively defined equivalence margin (+/-14.7%) when compared to the FDA-approved reference standard, 133Xe scintigraphy imaging.5 A summary of the study populations and outcomes are described below.

 References

1. Biological magnetic resonance imaging using laser-polarized 129Xe – PubMed. Accessed January 15, 2023. https://pubmed.ncbi.nlm.nih.gov/8028666/
2. Ruset IC, Ketel S, Hersman FW. Optical pumping system design for large production of hyperpolarized. Phys Rev Lett. 2006;96(5):053002. doi:10.1103/PhysRevLett.96.053002
3. Patz S, Muradian I, Hrovat MI, et al. Human Pulmonary Imaging and Spectroscopy with Hyperpolarized 129Xe at 0.2T. Acad Radiol. 2008;15(6):713-727. doi:10.1016/j.acra.2008.01.008
4. 214375s000lbl.pdf. Accessed January 15, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214375s000lbl.pdf
5. POLX_Phase-_III-_Readout.pdf. Accessed January 15, 2023. https://polarean.com/wp-content/uploads/2021/10/POLX_Phase-_III-_Readout.pdf
6. Polarean, Inc. Evaluation of Hyperpolarized 129Xe MRI as Compared to 133Xe Scintigraphy for the Assessment of Pulmonary Function in Patients Being Evaluated for Possible Lung Resection Surgery. clinicaltrials.gov; 2022. Accessed January 12, 2023. https://clinicaltrials.gov/ct2/show/NCT03417687
7. Polarean, Inc. Evaluation of Hyperpolarized 129Xe MRI as Compared to 133Xe Scintigraphy for the Assessment of Pulmonary Function in Patients Being Evaluated for Possible Lung Transplant Surgery. clinicaltrials.gov; 2020. Accessed January 12, 2023. https://clinicaltrials.gov/ct2/show/NCT03418090