Early Phase 1 Cystic Fibrosis Trial, Recruiting NCT06339593 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Cystic Fibrosis
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Early Phase 1 Cystic Fibrosis Trial, Recruiting

NCT06339593
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to provide written agreement to take part (or have a legal guardian provide this on their behalf)
  • People who have been taking a highly effective CF modulator medication (such as Trikafta) for more than 30 days
  • People who are willing and able to attend study visits and follow the study schedule
  • People who have a confirmed diagnosis of cystic fibrosis (CF) and have been prescribed a mechanical airway clearance therapy device
  • People aged 12 to 21 years old at the time of signing consent
  • People who are clinically stable, with no current respiratory tract infection or recent CF flare-ups
  • People whose CF treating doctor agrees to the study procedures (this applies to one specific part of the study only — confirm with trial site)
  • People who have had no changes to their regular ongoing CF treatments in the 28 days before joining the study
  • People who are able to cooperate with MRI scanning procedures

Who may not be able to join:

  • People who are unable to have an MRI scan for standard safety reasons, such as having certain metal implants in their body, or who experience severe anxiety in enclosed spaces (claustrophobia)
  • Females who could become pregnant and have a positive pregnancy test, or who are currently breastfeeding
  • People who are experiencing active breathing symptoms, such as wheezing, at the time of the MRI scan
  • People who have a chronic lung, liver, or pancreatic condition that is not related to CF
  • People who have any other condition that, in the opinion of the study investigator, would make participation unsafe, affect the study results, or prevent proper consent from being given

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Jason C Woods, PhD, Cincinnati Children's Hospital Medica Center

Phone: (513) 636-9973

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
5 January 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assessing functional lung abnormalities via Xenon MRI

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov