Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The purpose of this study is to look at lung ventilation in people with cystic fibrosis over time (1 year) using magnetic resonance imaging (MRI) with an inhaled contrast gas, and compare these measures to lung function assessed by spirometry and multiple breath nitrogen washout. This study also looks at how these measures change in response to a pulmonary exacerbation and treatment (if applicable). Over the span of a year, participants would be asked to complete 3-5 visits to the University of North Carolina at Chapel Hill (UNC). with each lasting up to 4 hours. If participants do not have a pulmonary exacerbation during the year they would be asked to complete 3 visits (one at enrollment, a second roughly 2 weeks later, and the third approximately a year later). If participants do experience a CF pulmonary exacerbation they would complete 5 visits (Visit 1, Visit 2, two exacerbation visits with one before treatment and the other after, and Visit 3 at one year after Visit 1). Only one exacerbation per participant will be tracked. Participants are eligible for this study if they are 18 years old or older, have Cystic Fibrosis (CF) with mild lung disease (FEV1 \>/= 60%), and can undergo an MRI. There are no known benefits for participating in this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must be ≥18 years of age

Non-smokers (<10 pack/year history and no active smoking in the past year)

Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic features/genotyping

No use of supplemental oxygen

Disqualifiers

Active or past smokers or vapers with less than 1 year since quitting or >10 pack-year smoking history

Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including

Occupation (past or present) of machinist, welder, or grinder;

Injury to the eye involving a metallic object

Trial population

Adults with cystic fibrosis and stable lung disease at the time of enrollment

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • 19F MRI

    Combination product

    Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: All Participants1 intervention

Trial outcomes

Primary outcomes

1

Change in Ventilation Defect Parameter (VDP) over 14 days

VDP measured at Day 1 and Day 14, expressed as a percentage of total lung volume

Time frame
Day 1 to Day 14
2

Change in VDP over 365 days

Average of VDP measured at Day 1 and Day 14; subtracted from VDP at Day 365, expressed as a percentage of total lung volume

Time frame
Day 1 to Day 365 (+/- 30 days)
3

Change in FLVlongtau2 over 14 days

FLVlongtau2 measured at Day 1 and Day 14, expressed as a percentage of total lung volume

Time frame
Day 1 to Day 14
4

Change in FLVlongtau2 over 365 days

Average of FLVlongtau2 measured at Day 1 and Day 14; subtracted from FLVlongtau2 at Day 365, expressed as a percentage of total lung volume

Time frame
Day 1 to Day 365 (+/- 30 days)

Secondary outcomes

1

Change in MRI severity score over 365 days

Change in MRI severity score from baseline to Day 365.

Time frame
Day 1 to Day 365 (+/- 30 days)
2

Correlation of MRI severity score with VDP at baseline.

Baseline is a mean of the VDP scores from Day 1 and Day 14 (expressed as percentage of lung). Correlation of MRI scores with VDP and FLVlongtau2

Time frame
Day 1 to Day 14
3

Correlation of MRI severity score with FLVlongtau2 at baseline.

Baseline is a mean of the FLVlongtau2 scores from Day 1 and Day 14 (expressed as percentage of lung). Correlation of MRI scores with VDP and FLVlongtau2

Time frame
Day 1 to Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Cystic Fibrosis Foundation

Collaborator