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NCT04994301Completed

Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients

Lung T1 MRI Assessments of Children With CF Initiating Trikafta Therapy

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

In this observational study, the investigators evaluate the sensitivity of T1-MRI to identify lung perfusion changes in pediatric patients with CF (age = 6-11) before and after initiating FDA-approved Trikafta therapy. The investigators compare these Lung T1 MRI assessments (% Normal lung perfusion) to currently best-available assessments of lung function in CF patients (i.e., MBW (LCI( and Spirometry (FEV1 % Predicted).

Status (registry)
Completed
Study type
Observational
Enrollment
48 (actual)
First submitted
29 Jul 2021
Start date
15 Dec 2020
Primary completion date
15 Dec 2023
Lead sponsor
University Hospitals Cleveland Medical Center
NCT number
NCT04994301

What you commit to

  • Study type: Observational
  • Participants enrolled: 48
  • From 15 Dec 2020 to the primary completion date, 15 Dec 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects with MRI contraindication (e.g., heart pacemaker, heart defibrillator, metal in within the body.

Other

  • Subject who cannot hold their breath for up to 15 seconds.
  • Subjects who are pregnant.

Who the study is looking for

  • Male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the F508del mutation.

Age in the registry: 5 years to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CS Mott Children's Hospital
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Riley Hospital for Children
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.