Feasibility, tolerability and safety of pediatric hyperpolarized ¹²⁹Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis

Background: Hyperpolarized ¹²⁹Xe is a promising contrast agent for MRI of pediatric lung function, but its safety and tolerability in children have not been rigorously assessed.

Objective: To assess the feasibility, safety and tolerability of hyperpolarized ¹²⁹Xe gas as an inhaled contrast agent for pediatric pulmonary MRI in healthy control subjects and in children with cystic fibrosis.

Materials and methods: Seventeen healthy control subjects (ages 6-15 years, 11 boys) and 11 children with cystic fibrosis (ages 8-16 years, 4 boys) underwent ¹²⁹Xe MRI, receiving up to three doses of ¹²⁹Xe gas prepared by either a commercially available or a homebuilt ¹²⁹Xe polarizer. Subject heart rate and SpO₂ were monitored for 2 min post inhalation and compared to resting baseline values. Adverse events were reported via follow-up phone call at days 1 and 30 (range ±7 days) post-MRI.

Results: All children tolerated multiple doses of ¹²⁹Xe, and no children withdrew from the study. Relative to baseline, most children who received a full dose of gas for imaging (10 of 12 controls and 8 of 11 children with cystic fibrosis) experienced a nadir in SpO₂ (mean -6.0 ± standard deviation 7.2%, P≤0.001); however within 2 min post inhalation SpO₂ values showed no significant difference from baseline (P=0.11). There was a slight elevation in heart rate (mean +6.6 ± 13.9 beats per minute [bpm], P=0.021), which returned from baseline within 2 min post inhalation (P=0.35). Brief side effects related to the anesthetic properties of xenon were mild and quickly resolved without intervention. No serious or severe adverse events were observed; in total, four minor adverse events (14.3%) were reported following ¹²⁹Xe MRI, but all were deemed unrelated to the study.

Conclusion: The feasibility, safety and tolerability of ¹²⁹Xe MRI has been assessed in a small group of children as young as 6 years. SpO₂ changes were consistent with the expected physiological effects of a short anoxic breath-hold, and other mild side effects were consistent with the known anesthetic properties of xenon and with previous safety assessments of ¹²⁹Xe MRI in adults. Hyperpolarized ¹²⁹Xe is a safe and well-tolerated inhaled contrast agent for pulmonary MR imaging in healthy children and in children with cystic fibrosis who have mild to moderate lung disease.