BEGIN Novel ImagiNG Biomarkers

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05517655
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • 129Xe — DRUG
    Rapid spatial mapping of lung, liver, and pancreatic structure and function is now possible with a combination of hyperpolarized 129Xe and traditional proton MRI, all absent sedation and ionizing radiation.

Study Details

To determine the treatment effect of triple-combination therapy in 6-8 year olds after presumed FDA approval, using rapid structural and functional pulmonary and abdominal MRI (UTE and 129Xe).

Key Dates

Start date
May 1, 2022
Status verified
Nov 2024
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pre Trikafta
    129Xe MRI
  • Experimental: Post Trikafta
    129Xe MRI

Primary Outcome Measure

Ventilation Defect Percentage change from baseline [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
Carrie StevensCincinnatiOhio45229-
University of VirginiaCharlottesvilleVirginia22903
Jamie Mata
Jamie Mata (PRINCIPAL_INVESTIGATOR)
Deborah Froh (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KSCarrie Stevens· Cincinnati, OHUniversity of Virginia· Charlottesville, VA

Related Studies