Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04995562 · ClinicalTrials.gov registry record · Phase 4

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

A Phase 4 study of Lungs; Developmental Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
Phase 4
Development phase
12
Enrollment target
1
Study location

NCT04995562: Recruiting Phase 4 study of Lungs; Developmental Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT04995562 is a Phase 4 study of Lungs; Developmental Disorder that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04995562, a Phase 4 study of Lungs; Developmental Disorder, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
Phase 4
Development phase
12 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • DRUG 129Xe

Study Locations (1)

Ohio

  • Megan Schmitt - Cincinnati

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-05-06
Est. Completion 2028-05-01
Phase Phase 4

What NCT04995562 shows while recruiting

NCT04995562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Lungs; Developmental Disorder appearing as the primary indexed condition, and to 1 intervention - of which 129Xe is the first listed.

NCT04995562 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT04995562 about?

NCT04995562 is a clinical study titled "Use of Hyperpolarized 129Xe MR Lung Imaging in Infants". 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 rad...

What is the current status of trial NCT04995562?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2020-05-06. Estimated completion is 2028-05-01.

What conditions does trial NCT04995562 study?

This clinical trial studies the following conditions: Lungs; Developmental Disorder.

What interventions are being tested in trial NCT04995562?

The interventions under investigation include: 129Xe (DRUG).

Who is sponsoring clinical trial NCT04995562?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04995562 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04995562's enrollment target sits among peer trials

12 1914th of 2000 higher than 70 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02602769 · 12 participants

    Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome

  • NCT02605421 · 12 participants · Phase 2

    Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

  • NCT02619448 · 12 participants · Early Phase 1

    Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC

  • NCT03311503 · 12 participants · Phase 1

    Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04995562, the US trial registry maintained by the National Library of Medicine. NCT04995562 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.