BEGIN Novel ImagiNG Biomarkers

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 8
Healthy Volunteers: f
View:

• Written informed consent (and assent where appropriate) obtained from the subject or subject's legal representative.

• Willingness to adhere to the study-visit schedule and other protocol requirements.

• Ages 6-8 years old at baseline MRI visit (may be enrolled up to 60 days before 6th birthday).

• Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

‣ Sweat chloride equal to or greater than 60 mEq/liter by quantitative pilocarpine iontophoresis test

⁃ Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene

• Physician intent to prescribe triple-combination therapy

• Clinically-stable with no respiratory tract infection at the time of enrollment.

• No change in chronic maintenance therapies in the 28 days prior to enrollment.

• Ability to cooperate with MRI procedures

Locations
United States
Kansas
University of Kansas Medical Center
ACTIVE_NOT_RECRUITING
Kansas City
Ohio
Carrie Stevens
ACTIVE_NOT_RECRUITING
Cincinnati
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Carrie Stevens, BS
carrie.stevens@cchmc.org
(513) 636-9973
Backup
Penny New, BS
Penny.New@cchmc.org
(513) 636-9973
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 44
Treatments
Experimental: Pre Trikafta
129Xe MRI
Experimental: Post Trikafta
129Xe MRI
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: University of Iowa, University of Virginia, University of Kansas

This content was sourced from clinicaltrials.gov