NCT06339593RecruitingEarly phase 1
Regional Monitoring of CF Lung Disease
Regional Monitoring of CF Lung Disease After Changes in Mechanical Airway-clearance Treatment
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 5 Jan 2024
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Cystic fibrosis
- NCT number
- NCT06339593
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 5 Jan 2024 to the primary completion date, 31 Jan 2028
- 1 site 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.
Prior treatment
- Standard MRI exclusions (metal implants, claustrophobia).
Other illness
- 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.
Other
- For females of childbearing potential: Positive urine pregnancy test or Lactating.
- Acute respiratory symptoms (e.g., wheezing) at the time of the MRI
Who the study is looking for
- 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.
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.