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New treatment option for Cystic Fibrosis
Official title Regional Monitoring of CF Lung Disease
ClinicalTrials.gov ID: NCT06339593
What this study is testing
What is Hyperpolarized Xe129?
Hyperpolarized Xe129 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for cystic fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join 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...
- 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...
- 8 No change in chronic maintenance therapies in the 28 days prior to enrollment.
- 9 Ability to cooperate with MRI procedures.
You likely can't join 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.