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Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Apr 30, 2026 to May 1, 2027 Completion date: Apr 30, 2027 to May 1, 2028 · Site contact updatedv6 Show 2 more changesShow less
    • Completion date: Apr 30, 2027 to May 1, 2028
    • Site contact updated
  2. Notable Primary completion date: Apr 30, 2025 to Apr 30, 2026 Completion date: Apr 30, 2025 to Apr 30, 2027v5 Show 1 more changeShow less
    • Completion date: Apr 30, 2025 to Apr 30, 2027
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Minor Study site revisedv3 See this version in full on ClinicalTrials.gov ↗
  5. Notable Primary and study completion dates: Apr 30, 2023 to Apr 30, 2025v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04995562
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions Lungs; Developmental Disorder
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov