Cystic Fibrosis study: Magnetic Resonance Imaging vs Lung Clearance Index
Official title Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease
ClinicalTrials.gov ID: NCT02740868
What this study is testing
What is Xenon-129 and Perfluoropropane (19F)?
An investigational inhaled gas mixture being studied for use in magnetic resonance imaging of the lungs in cystic fibrosis patients.
Also referred to as 129Xe, 19F.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how well the MRI images are made and how consistent they are, and will examine changes in lung structure and function in the disease groups compared with healthy people.
- Who it's for
- Adults who have cystic fibrosis or asthma, and healthy adults who have no lung disease.
- What's involved
- Participants will have MRI scans of their lungs using xenon‑129 gas and a fluorinated gas. The scans will be repeated to check reproducibility and to see how the lungs look and work.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participants male and female aged 8 years old and older.
- Participants have no smoking history.
- For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
- Participants should have a FEV1%pred value greater than 40%.
- Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
You likely can't join if
- Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or...
- Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
- Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
- Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
- Participant is unable to perform spirometry or plethysmography maneuvers.
- Participant is pregnant or lactating.
See the full eligibility criteria
- Participants male and female aged 8 years old and older.
- Participants have no smoking history.
- For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
- Participants should have a FEV1%pred value greater than 40%.
- Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
- Participant must be able to perform a breath hold for 20s or less.
- Participant able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater).
- Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material.
- Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
- Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
- Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
- Participant is unable to perform spirometry or plethysmography maneuvers.
- Participant is pregnant or lactating.
- In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
- Participant has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio...
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.