Cystic Fibrosis Trial, Recruiting NCT06057714 Sponsor: University of North Carolina, Chapel Hill Condition: Cystic Fibrosis
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Cystic Fibrosis Trial, Recruiting

NCT06057714
Recruiting Not Applicable

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 18 years of age or older
  • People who have never smoked, or who smoked very little (fewer than 10 pack-years total) and have not smoked at all in the past year
  • People who have been diagnosed with cystic fibrosis through standard testing (such as a sweat test, physical features, or genetic testing)
  • People who do not use supplemental (extra) oxygen
  • People whose lung function has been stable — within 10% of their personal best over the last 6 months, with no lung infection flare-ups in the past 4 weeks, and a breathing test result (FEV1) of at least 60% of what is expected for their age and size
  • People who have read and signed a consent form showing they have been fully informed about the trial
  • People who are willing and able to attend scheduled visits and follow the trial procedures

Who may not be able to join:

  • People who currently smoke or vape, or who quit less than one year ago, or who have a smoking history of more than 10 pack-years
  • People who are unable to have a 3.0-Tesla MRI scan of the lungs and chest due to safety concerns, including any of the following:
    • Current or past work as a machinist, welder, or grinder
    • A past eye injury involving a metal object
    • A past body injury from a metal object such as a bullet or shrapnel
    • Having a heart pacemaker or defibrillator
    • Having aneurysm clips in the brain or body
    • Having a carotid artery vascular clamp
    • Having a neurostimulator device
    • Having an insulin pump or infusion pump
    • Having an implanted drug delivery device that is not confirmed to be MRI-safe (for example, one placed at another facility or more than 10 years old)
    • Having a bone growth or fusion stimulator
    • Having a cochlear implant or other ear implant
    • Having any type of prosthesis (such as an eye or penile prosthesis)
    • Having an artificial limb or joint
    • Having non-removable electrodes on the body, head, or brain
    • Having stents, filters, or coils inside blood vessels
    • Having a spinal or brain fluid shunt
    • Having a Swan-Ganz catheter
    • Having any implant held in place by a magnet
    • Using a patch-based medication delivery system (such as a nitroglycerin skin patch)
    • Having an intrauterine device (IUD) or diaphragm that is not MRI-safe
    • Having permanent cosmetic tattooing (such as tattooed eyeliner or lip liner), or tattoos covering more than 25% of the body
    • Having body piercings that cannot be removed before the MRI
    • Having any metal fragments in the body
    • Having internal pacing wires
    • Having metal or wire mesh implants
    • Having a hearing aid that cannot be removed before the MRI
    • Having dentures that cannot be removed before the MRI
    • Having claustrophobia (fear of enclosed spaces)
  • People who are unable to breathe in the gas mixture used during the scan
  • People who have facial hair that could prevent the breathing mask from fitting properly, and who are unwilling to shave before each MRI session
  • People who have had any changes to their cystic fibrosis medications — including experimental treatments — in the past 28 days
  • People with another serious medical or psychiatric condition, or abnormal lab results, that the trial doctor believes could make participation unsafe or affect the trial results
  • People who are pregnant; women who could become pregnant will need to have a confirmed negative pregnancy test on the day of each MRI scan, taken before the scan begins

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 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jennifer L Goralski, MD, UNC Chapel Hill

Phone: 919-445-0331

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 January 2021
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Ventilation Defect Parameter (VDP) over 14 days; Change in VDP over 365 days; Change in FLVlongtau2 over 14 days; Change in FLVlongtau2 over 365 days; Change in VDP occurring with a protocol-defined CF pulmonary exacerbation; Change in FLVlongtau2 occurring with a protocol-defined CF pulmonary exacerbation

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: 19 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