Overview
Hyperpolarized Xenon-129 (Xe-129) is a contrast agent used in the lung's clinical magnetic resonance imaging (MRI). Lung MRIs are challenging due to the low proton density of this tissue, as well as the presence of artifacts due to respiration and cardiovascular pulsation movement and air–tissue interfaces. The use of hyperpolarized noble gases makes lung MRIs feasible. They undergo a process that increases nuclear polarization up to five orders of magnitude, leading to a higher MRI signal. Helium-3 (He-3) is the one most commonly used due to its strong signal and favorable safety profile, but its use in other applications has affected its availability. Xe-129 has a lower cost, and adverse effects are normally resolved shortly after administration. In December 2022, the FDA approved the use of hyperpolarized Xe-129 for use with MRI for the evaluation of lung ventilation. Hyperpolarized Xe-129 is chemically identical to non-polarized Xe-129, and xenon is a clear, colorless, monoatomic, inert, stable, noble gas.
Background
Hyperpolarized Xenon-129 (Xe-129) is a contrast agent used in the lung's clinical magnetic resonance imaging (MRI). Lung MRIs are challenging due to the low proton density of this tissue, as well as the presence of artifacts due to respiration and cardiovascular pulsation movement and air–tissue interfaces. The use of hyperpolarized noble gases makes lung MRIs feasible. They undergo a process that increases nuclear polarization up to five orders of magnitude, leading to a higher MRI signal. Helium-3 (He-3) is the one most commonly used due to its strong signal and favorable safety profile, but its use in other applications has affected its availability. Xe-129 has a lower cost, and adverse effects are normally resolved shortly after administration. In December 2022, the FDA approved the use of hyperpolarized Xe-129 for use with MRI for the evaluation of lung ventilation. Hyperpolarized Xe-129 is chemically identical to non-polarized Xe-129, and xenon is a clear, colorless, monoatomic, inert, stable, noble gas.
Indication
Hyperpolarized Xenon-129 is a contrast agent indicated for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
Associated Conditions
- Ventilation of the Lung
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Polarean, Inc. | 80534-1000 | RESPIRATORY (INHALATION) | 75 mL in 1 L | 1/4/2023 | |
| Polarean, Inc. | 80534-6350 | RESPIRATORY (INHALATION) | 63.5 L in 1 1 | 1/4/2023 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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