- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331302
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
November 2, 2020 updated by: Y. Michael Shim, MD, University of Virginia
Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation.
This study is conducted as a pilot study with intention to conduct a larger clinical trial.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure.
The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial.
The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard).
In this study we will test the imaging parameters and techniques.
We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI.
Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.
Study Type
Interventional
Enrollment (Anticipated)
30
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: Sarah Struchen, RN
- Phone Number: 4342436074
- Email: SS8YM@hscmail.mcc.virginia.edu
Study Contact Backup
- Name: Roselove Nunoo-Asare, RT
- Phone Number: 4342437363
- Email: RNN3B@hscmail.mcc.virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Health System
-
Contact:
- Sarah Struchen, RN
- Phone Number: 434-243-6074
- Email: SS8YM@hscmail.mcc.virginia.edu
-
Contact:
- Roselove Nunoo-Asare, RT
- Phone Number: 434-243-6074
- Email: RNN3B@hscmail.mcc.virginia.edu
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have a diagnosis of COPD
- at their clinical baseline on the day of imaging
- must be clinically stable in order to participate in the study.
- COPD subjects will be categorized according to the GOLD
- Current/Former SmokerSubjects
- must have a smoking history ≥ 10 pack years
Exclusion Criteria:
- Dx of asthma
- Continuous oxygen use at home
- Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
- FEV1 percent predicted less than 25%
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
- Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
- Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
- History of congenital cardiac disease, chronic renal failure, or cirrhosis
- Inability to understand simple instructions or to hold still for approximately 10 seconds
- History of respiratory infection within 2 weeks prior to the MR scan
- History of MI, stroke and/or poorly controlled hypertension.
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: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: COPD patients - Xe-133
COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)
|
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
Other Names:
|
EXPERIMENTAL: COPD patients - Hyperpolarized Xe-129
COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)
|
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilation imaging resolution comparison between MRI and scintigraphy
Time Frame: 12 months
|
Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
September 1, 2018
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
October 31, 2017
First Submitted That Met QC Criteria
October 31, 2017
First Posted (ACTUAL)
November 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20053 (Other Grant/Funding Number: OHSU Circle of Giving)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Undecided for now.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
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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