Regional Monitoring of CF Lung Disease

Recruiting now · Early Phase 1

Conditions studied: Cystic Fibrosis

In brief

The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.

Key facts

Study ID: NCT06339593
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 60
Starts: 2024-01-05
Expected to finish: 2028-01-01
Last updated by the study team: 2026-01-14

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1 Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
2 Use of highly effective modulators for more than 30 days (ie. Trikafta) 3 Willingness and ability to adhere to the study visit schedule and other protocol requirements.
4 Documentation of a CF diagnosis with prescription of Mechanical ACT 5 Ages 12-21 inclusive, at the time of consent. 6 Clinically stable with no respiratory tract infection or recent exacerbations. 7 Treating CF physician agreeable to study procedures. Only applicable to Aim 3.
8 No change in chronic maintenance therapies in the 28 days prior to enrollment.
9 Ability to cooperate with MRI procedures.

You may not qualify if…

Standard MRI exclusions (metal implants, claustrophobia).
For females of childbearing potential: Positive urine pregnancy test or Lactating.
Acute respiratory symptoms (e.g., wheezing) at the time of the MRI
Chronic lung or liver or pancreatic disease not related to CF.
Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Where it is running

Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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