NCT06339593 Regional Monitoring of CF Lung Disease
| NCT ID | NCT06339593 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-01-05 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. Standard MRI exclusions (metal implants, claustrophobia). 2. For females of childbearing potential: Positive urine pregnancy test or Lactating. 3. Acute respiratory symptoms (e.g., wheezing) at the time of the MRI 4. Chronic lung or liver or pancreatic disease not related to CF. 5. 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.
Contact & Investigator
Jason C Woods, PhD
PRINCIPAL INVESTIGATOR
Cincinnati Children's Hospital Medica Center
Frequently Asked Questions
Who can join the NCT06339593 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06339593 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06339593 currently recruiting?
Yes, NCT06339593 is actively recruiting participants. Contact the research team at carrie.stevens@cchmc.org for enrollment information.
Where is the NCT06339593 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06339593 clinical trial?
NCT06339593 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Jason C Woods, PhD at Cincinnati Children's Hospital Medica Center. The trial plans to enroll 60 participants.