Can a special lung scan catch cystic fibrosis damage earlier than standard tests?
NCT ID NCT04994301
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are studying whether a specialized lung MRI scan can detect changes in lung blood flow in children with cystic fibrosis before and after they start Trikafta, an FDA-approved treatment. The study enrolls 48 children aged 6 to 11 who have cystic fibrosis and at least one copy of the F508del mutation. The team compares the MRI results to standard lung function tests, including spirometry and multiple breath washout, to see if the scan offers a more sensitive way to track early lung disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lung T1 MRI, a specialized imaging scan used to measure lung perfusion
- What this could lead to
- If it works, this imaging approach could give doctors a more sensitive way to track early lung changes in children with cystic fibrosis, potentially catching problems before standard breathing tests do.
- What could go wrong
- This is a small observational study of 48 children, so the results may not apply to all patients with cystic fibrosis. MRI scans require holding still and holding breath, which can be hard for young children, and the technique may not prove reliable enough for routine use.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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48 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with cystic fibrosis (CF) who are planning to start Trikafta therapy once approved
- Ages
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5 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: • Male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the F508del mutation. Exclusion Criteria: * Subject who cannot hold their breath for up to 15 seconds. * Subjects who are pregnant. * Subjects with MRI contraindication (e.g., heart pacemaker, heart defibrillator, metal in within the body.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
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Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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