Actively Recruiting

Early Phase 1
Age: 12Years - 21Years
All Genders
NCT06339593

Regional Monitoring of CF Lung Disease

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-14

60

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Regional Monitoring of CF Lung Disease

Who Can Participate

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and assent when applicable obtained from subject or legal representative
  • Use of highly effective modulators for more than 30 days (e.g., Trikafta)
  • Willingness and ability to follow study visit schedule and protocol requirements
  • Documented diagnosis of Cystic Fibrosis with prescription of Mechanical Airway Clearance Treatment
  • Ages 12 to 21 years inclusive at time of consent
  • Clinically stable with no respiratory infection or recent exacerbations
  • Treating CF physician agrees to study procedures (applicable to Aim 3 only)
  • No change in chronic maintenance therapies within 28 days prior to enrollment
  • Ability to cooperate with MRI procedures
Not Eligible

You will not qualify if you...

  • Standard MRI exclusions such as metal implants or claustrophobia
  • Positive urine pregnancy test or lactating for females of childbearing potential
  • Acute respiratory symptoms (e.g., wheezing) at time of MRI
  • Chronic lung, liver, or pancreatic disease not related to Cystic Fibrosis
  • Any other condition that could prevent informed consent, make participation unsafe, complicate data interpretation, or interfere with study objectives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

C

Carrie Stevens, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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