Actively Recruiting
BEGIN Novel ImagiNG Biomarkers
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-11-21
44
Participants Needed
3
Research Sites
339 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
U
University of Kansas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
BEGIN Novel ImagiNG Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and assent when appropriate obtained
- Willingness to follow the study visit schedule and protocol requirements
- Children aged 6 to 8 years at baseline MRI visit (enrollment allowed up to 60 days before 6th birthday)
- Confirmed cystic fibrosis diagnosis by clinical features and either sweat chloride ≥60 mEq/liter or two CFTR gene mutations
- Physician plans to prescribe triple-combination therapy
- Clinically stable with no respiratory infection at enrollment
- No changes in chronic maintenance therapies in the 28 days before enrollment
- Ability to cooperate with MRI procedures
You will not qualify if you...
- Current use of ivacaftor therapies with at least one gating mutation (e.g., G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D)
- Acute respiratory symptoms such as wheezing at MRI time
- Acute respiratory infection within 28 days before enrollment
- Chronic lung disease not related to cystic fibrosis
- Chronic liver disease not related to cystic fibrosis
- Acute pancreatitis by clinical criteria
- Chronic pancreatic disease not related to cystic fibrosis
- Any physical condition risking safety or study data quality per investigator
- Any other condition impairing consent, safety, data interpretation, or study objectives as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
2
Carrie Stevens
Cincinnati, Ohio, United States, 45229
Active, Not Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Carrie Stevens, BS
CONTACT
P
Penny New, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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