- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316379
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration (HpXeMRCal)
February 21, 2023 updated by: Children's Hospital Medical Center, Cincinnati
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 adults for the purposes of obtaining optimal images through MRI.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center.
Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses for up to four MRI scans.
Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans.
In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected.
Follow up will be done one day and 30 days from the MRI date.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carrie Stevens, BS
- Phone Number: 513-636-9973
- Email: carrie.stevens@cchmc.org
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Jason C Woods, Ph.D
- Phone Number: 513-803-4463
- Email: jason.woods@cchmc.org
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ages 18 years and older
- Participant must be able to hold their breath for up to 16 seconds
Exclusion Criteria:
- 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.
- Standard MRI exclusions (metal, implants).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperpolarized 129 Xenon
Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI to optimize acquisition of images for adults vs. proton MR imaging.
These scans, utilizing volunteers for calibration, may be utilized through this study to optimize the scan details.
|
During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
Time Frame: Day 1
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jason C Woods, Ph.D., 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 Major Dates
Study Start
February 1, 2015
Primary Completion (Anticipated)
August 24, 2024
Study Completion (Anticipated)
August 24, 2025
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-7643
- IND 123577 (Other Identifier: FDA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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