NCT02272049

Brief Summary

The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
41mo left

Started Dec 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Dec 2014Aug 2029

First Submitted

Initial submission to the registry

September 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

14.1 years

First QC Date

September 12, 2014

Last Update Submit

February 12, 2026

Conditions

Keywords

Respiratory

Outcome Measures

Primary Outcomes (1)

  • Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI

    quantify the measurement agreement between the ventilated volume of healthy lungs predicted via 129 Xe MRI and the ventilated volume of the pleural cavity predicted via proton MRI

    Day 1

Study Arms (1)

Hyperpolarized 129 Xenon

EXPERIMENTAL

Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI (less for children) to optimize acquisition of images for children and adults vs. proton MR imaging

Drug: Hyperpolarized 129 Xenon

Interventions

During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans

Also known as: HP 129 Xe
Hyperpolarized 129 Xenon

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 6 and up
  • Participant must be able to hold breath for up to 16 seconds

You may not qualify if:

  • History of heart defect
  • Pregnancy or positive pregnancy test
  • History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month
  • Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week
  • Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula
  • Participant is claustrophobic and unable to tolerate the imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Jason C. Woods, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Stevens, BS

CONTACT

Kelly Thornton, BS

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

October 22, 2014

Study Start

December 1, 2014

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations