Idiopathic Pulmonary FibrosisPhase 2NCT04677426
129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
A Phase 2 study testing Hyperpolarized Xe129 in people with Idiopathic Pulmonary Fibrosis and Hypersensitivity Pneumonitis, run by University of Kansas Medical Center.
Trial summary
This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a… 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, Hypersensitivity Pneumonitis
- What is being tested?
- Hyperpolarized Xe129
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Aug 2022
- Phase
- Phase 2
- 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
- Adults > 18 years of age
- Diagnosis of progressive chronic HP, IPF as determined by MDD discussion (historical or during screening period) OR normal control (no history of known lung disease, no abnormal parenchymal or airway findings on CT examination and no values outside of the normal for FVC, FEV1, TLC, and DLCO.)
- FVC % Predicted >45%
- DLCO % Predicted >30%
- Progressive lung disease as defined by one of the following criteria within 24 months of screening visit
- Relative decline in the FVC ≥ 10% of the predicted value
Show all 9Show fewer
- Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and worsening of respiratory symptoms
- Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and an increased extent of fibrosis on prior clinical high-resolution CT
- Worsening of respiratory symptoms and an increased extent of fibrosis on high-resolution CT.
Who cannot join
- Stable FVC over 2-year period as determined by study physician
- Unstable cardiac condition within 6 months of screening as determined by study physician
About this study
This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.
- Being tested
- Hyperpolarized Xe129
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xe129Drug
Also called Xenon, HP 129Xe
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to assess patients with cHP and IPF.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Progressive Interstitial Lung Disease | Experimental | Assess the intra-visit reliability and sensitivity to progression of 129Xe MR imaging measurements using a standardized imaging protocol in subjects with IPF and cHP. Receives: Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC:Barrier Ratio
RBC:Barrier ratio will be determined using 129 Xenon MRI in 2 successive scans on two separate days 6 months apart. Same-day Repeated measures will be used to assess reliability of RBC:Barrier. Data acquired at 6 months will be correlated with FVC.
Measured: RBC:Barrier will be assessed at Baseline and at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 May 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Sponsor withdrew Funding
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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677426
- Sponsor's protocol ID
- 00146495
- Status last verified
- Sep 2022
- First submitted
- 16 Dec 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
- ClinicalTrials.gov ID
- NCT04677426
- Acronym / sponsor ID
- 00146495
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Duke University, Children's Hospital Medical Center, Cincinnati, Boehringer Ingelheim
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- 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.
This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Progressive Interstitial Lung Disease | Experimental | Drug: Hyperpolarized Xe129Assess the intra-visit reliability and sensitivity to progression of 129Xe MR imaging measurements using a standardized imaging protocol in subjects with IPF and cHP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults > 18 years of age
- Diagnosis of progressive chronic HP, IPF as determined by MDD discussion (historical or during screening period) OR normal control (no history of known lung disease, no abnormal parenchymal or airway findings on CT examination and no values outside of the normal for FVC, FEV1, TLC, and DLCO.)
- FVC % Predicted >45%
- DLCO % Predicted >30%
- Progressive lung disease as defined by one of the following criteria within 24 months of screening visit
Key exclusion criteria (2 listed)
- Stable FVC over 2-year period as determined by study physician
- Unstable cardiac condition within 6 months of screening as determined by study physician
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 Xe129Also: Xenon, HP 129XeWhether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to assess patients with cHP and IPF. | Drug | Subjects with Progressive Interstitial Lung Disease |
Primary outcome
RBC:Barrier Ratio
Time frame: RBC:Barrier will be assessed at Baseline and at 6 months.
RBC:Barrier ratio will be determined using 129 Xenon MRI in 2 successive scans on two separate days 6 months apart. Same-day Repeated measures will be used to assess reliability of RBC:Barrier. Data acquired at 6 months will be correlated with FVC.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized Xe129 in people with Idiopathic Pulmonary Fibrosis and Hypersensitivity Pneumonitis, run by University of Kansas Medical Center.
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 9 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
RBC:Barrier Ratio (time frame: RBC:Barrier will be assessed at Baseline and at 6 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 10 Sep 2022.