Idiopathic Pulmonary FibrosisPhase 1NCT02478268
Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
A Phase 1 study testing Hyperpolarized 129-Xenon gas and MRI in people with Idiopathic Pulmonary Fibrosis, run by Bastiaan Driehuys at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Hyperpolarized 129-Xenon gas and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 26 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer (technical optimization)
- Outpatients of either gender, age > 18.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Clinical diagnosis of IPF by established means
Who cannot join
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
- Subject does not fit into 129Xe vest coil used for MRI
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- Subject cannot hold his/her breath for 15 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
- Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27713
University of Wisconsin Madison
Madison, Wisconsin, 53792
About this study
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.
Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Hyperpolarized 129-Xenon gas, MRI
- Keywords
- idiopathic pulmonary fibrosis, xenon gas
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129-Xenon gasDrug
Also called Hyperpolarized 129Xe
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRIDevice
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with idiopathic pulmonary fibrosis | Active comparator | Not described Receives: Drug: Hyperpolarized 129-Xenon gas; Device: MRI |
| Healthy volunteers | Active comparator | Not described Receives: Drug: Hyperpolarized 129-Xenon gas; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung function as measured by ventilation defect percentage (VDP)
We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline
Measured: 12 months
Secondary outcomes (1)
Change in lung function as measured by gas exchange defect percentage (EDP)
Although the study is powered on ventilation defect percentage, we expect regional gas exchange defects to be a more sensitive marker of progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion26 Sep 2020
- Study completion26 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Joseph Mammarappallil, M.D., Principal investigator, Duke UniversityBastiaan Driehuys, Ph.D., Study director, Duke UniversitySean B Fain, Ph.D., Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478268
- Sponsor's protocol ID
- Pro00060259
- Other IDs
- R01HL126771
- Status last verified
- Oct 2021
- First submitted
- 16 Jun 2015
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02478268
- Acronym / sponsor ID
- Pro00060259
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- idiopathic pulmonary fibrosis, xenon gas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2015
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.
Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with idiopathic pulmonary fibrosis | Active comparator | Drug: Hyperpolarized 129-Xenon gas, Device: MRI |
| Healthy volunteers | Active comparator | Drug: Hyperpolarized 129-Xenon gas, Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteer (technical optimization)
- Outpatients of either gender, age > 18.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Clinical diagnosis of IPF by established means
Key exclusion criteria (10 listed)
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129-Xenon gasAlso: Hyperpolarized 129XeHyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. | Drug | Healthy volunteers, Patients with idiopathic pulmonary fibrosis |
| MRIConventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. | Device | Healthy volunteers, Patients with idiopathic pulmonary fibrosis |
Primary outcome
Change in lung function as measured by ventilation defect percentage (VDP)
Time frame: 12 months
We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline
1 secondary outcome
Change in lung function as measured by gas exchange defect percentage (EDP)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Mammarappallil, M.D. principal investigator
Duke University
Bastiaan Driehuys, Ph.D. study director
Duke University
Sean B Fain, Ph.D. study director
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized 129-Xenon gas and MRI in people with Idiopathic Pulmonary Fibrosis, run by Bastiaan Driehuys at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung function as measured by ventilation defect percentage (VDP) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.