Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Conditions

• Lungs; Developmental Disorder

Eligibility Criteria

Sex

ALL

Age

N/A - 6 Months

Healthy Volunteers

Not accepted

Interventions

• 129Xe — DRUG
  Inhaled contrast for MRI

Study Details

Abnormalities of the lungs are common in newborns and can include aspiration or infectious pneumonia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), pulmonary hypertension (PH), congenital diaphragmatic hernia (CDH), and other abnormalities of lung development. Diagnostic radiography is commonly used in this population to differentiate diagnosis and to assess changes after treatment. While X-ray and CT provide quality imaging, they also expose infants to ionizing radiation. MR imaging offers a safe, non-ionizing alternative. However, imaging lungs via 1H MR is intrinsically difficult due to multiple air-tissue interfaces within the lungs causing local gradients and severe magnetic field susceptibility, which leads to an exceedingly short effective transverse relaxation time (T2\*). Additionally, the lungs have low proton density, which along with the short T2\* results in low signal to noise ratio, and the physiological motion caused by respiration and cardiac pulsation further reduces lung signal. The development of more powerful hardware, along with faster MRI techniques, has enabled detailed noninvasive 1H MR imaging of pulmonary tissues. Additionally, the development of inhaled hyperpolarized gas MRI has led to breakthroughs in the ability to visualize and quantify regional ventilation and alveolar size.

Key Dates

Start date

May 6, 2020

Status verified

Jan 2026

Primary completion

May 1, 2027

Completion

May 1, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Oxygen with nasal cannula
  6 infants on oxygen with nasal cannula
• Experimental: HFNC, CPAP, or RAM cannula
  6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula

Primary Outcome Measure

Ventilation defect percentage (VDP) [ Time Frame: 1 day ]

Central Contacts

• Megan Schmitt, RN
  (513) 636-9348
  [email protected]
• Carrie Stevens
  (513) 636-9973
  [email protected]

Locations (1)

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