RECRUITING

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Quick Facts

Study Start:2020-05-06
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04995562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female
  2. * Any age NICU inpatient who is clinically stable and with adequate temperature control to tolerate MRI as determined by the primary clinical team
  3. * Age 0 - 6 months
  4. * NICU patient on oxygen with a nasal cannula (≤ 2L per minute) (unchanged - supplemental O2 for minimum 24 hours)
  5. * Maintaining SpO2 \> 88% on nasal O2
  6. * Age 0 - 6 months
  7. * 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%.
  8. * Maintaining SpO2 \> 88% on nasal O2
  1. * General anesthesia within 24 hours prior to MRI or other sedation (e.g. morphine, Versed, fentanyl) within the last 4 hours.
  2. * Extracorporeal membrane oxygenation (ECMO) support
  3. * Evidence of any respiratory infection within 1 week of testing (imaging may be rescheduled for a common viral infection such as a cold).
  4. * Suspected muscular dystrophy or neurologic disorder that may affect lung development.
  5. * Significant genetic or chromosomal abnormalities that may affect lung development
  6. * Congenital heart disease
  7. * Uncontrolled atrial or ventricular arrhythmia
  8. * Open surgical wounds
  9. * Need for inotropic support
  10. * Need for vasodilator agents
  11. * Need for high level of respiratory support (i.e. FiO2 \>50%, and/or higher respiratory support than listed in Cohort 2 Inclusion Criteria, such as invasive ventilation).
  12. * Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology (e.g., contraindicated support/implant equipment that is not MR compatible).
  13. * Infant size not compatible with NICU MRI scanner (\~\>4.5kg).

Contacts and Locations

Study Contact

Megan Schmitt, RN
CONTACT
(513) 636-9348
Megan.Schmitt@cchmc.org
Carrie Stevens
CONTACT
(513) 636-9973
carrie.stevens@cchmc.org

Principal Investigator

Jason Woods, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Megan Schmitt
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Jason Woods, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-06
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-05-06
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Lungs; Developmental Disorder