Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

NCT04995562 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Xe and Neonates_2019-0810
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lungs; Developmental Disorder

Keywords

129 Xe MRI; hyperpolarized xenon; neonates; nasal cannula; HFNC; CPAP; RAM cannula

Outcome Measures

Primary Outcomes (1)

• Ventilation defect percentage (VDP)

  To calculate the percentage of the lung that is ventilated with 129Xe gas. This is an indicator of lung ventilation. The lung function outcome will be measured using hyperpolarized 129Xe MRI, wherein hyperpolarized 129Xe is inhaled and its distribution is imaged within the lungs. Different MRI pulse sequences are used to obtain different functional information about the lungs. VDP will be assessed using a 2D spoiled gradient echo sequence.

  1 day

Secondary Outcomes (1)

• Apparent diffusion coefficient (ADC)

  1 day

Study Arms (2)

Oxygen with nasal cannula

EXPERIMENTAL

6 infants on oxygen with nasal cannula

Drug: 129Xe

HFNC, CPAP, or RAM cannula

EXPERIMENTAL

6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula

Drug: 129Xe

Interventions

129Xe DRUG

Inhaled contrast for MRI

HFNC, CPAP, or RAM cannula; Oxygen with nasal cannula

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female
• Any age NICU inpatient who is clinically stable and with adequate temperature control to tolerate MRI as determined by the primary clinical team
• Cohort 1
• Age 0 - 6 months
• NICU patient on oxygen with a nasal cannula (≤ 2L per minute) (unchanged - supplemental O2 for minimum 24 hours)
• Maintaining SpO2 \> 88% on nasal O2
• Cohort 2
• Age 0 - 6 months
• NICU patient who requires a slightly higher level of respiratory support (with High Flow Nasal Cannula \> 2L per minute, CPAP, or RAM cannula and O2 unchanged for minimum 24 hours), with FiO2 \< 50%.
• Maintaining SpO2 \> 88% on nasal O2

You may not qualify if:

• General anesthesia within 24 hours prior to MRI or other sedation (e.g. morphine, Versed, fentanyl) within the last 4 hours.
• Extracorporeal membrane oxygenation (ECMO) support
• Evidence of any respiratory infection within 1 week of testing (imaging may be rescheduled for a common viral infection such as a cold).
• Suspected muscular dystrophy or neurologic disorder that may affect lung development.
• Significant genetic or chromosomal abnormalities that may affect lung development
• Congenital heart disease
• Uncontrolled atrial or ventricular arrhythmia
• Open surgical wounds
• Need for inotropic support
• Need for vasodilator agents
• Infant size not compatible with NICU MRI scanner (\~\>4.5kg).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Megan Schmitt

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jason Woods, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Schmitt, RN

CONTACT

(513) 636-9348; Megan.Schmitt@cchmc.org

Carrie Stevens

CONTACT

(513) 636-9973; carrie.stevens@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study includes 2 cohorts: 6 infants on oxygen with nasal cannula, and 6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: August 9, 2021
• Study Start: May 6, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)