Actively Recruiting
BEGIN Novel ImagiNG Biomarkers for Cystic Fibrosis in Children Ages 6 to 8 Using Advanced 129Xe MRI
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-11-21
44
Participants Needed
3
Research Sites
N/A
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
Researchers are investigating the impact of triple-combination therapy on children aged 6 to 8 with cystic fibrosis (CF). This study aims to use advanced MRI techniques to provide more sensitive and detailed measurements of lung, liver, and pancreas changes than traditional methods. These insights may help personalize treatment for younger CF patients who show mild symptoms and are clinically stable. The study uses hyperpolarized 129Xe MRI combined with traditional proton MRI to rapidly map structural and functional changes in the lungs and abdomen without sedation or radiation exposure. Participants will be assessed before starting triple-combination therapy and again after treatment to measure changes over one year. The study is non-randomized and follows patients through pre- and post-treatment imaging. During the study, children will undergo MRI scans to evaluate ventilation defects in the lungs and pancreas volume, along with other abdominal and lung measurements. Researchers will monitor changes at baseline and after one year of therapy. The study requires cooperation with MRI procedures and stability in health without recent infections or treatment changes. The total participation period includes baseline and follow-up visits over a year to track treatment response and organ changes.
CONDITIONS
Brief Title
BEGIN Novel ImagiNG Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and assent if applicable
- Willingness to follow the study visit schedule and protocol
- Age between 6 and 8 years at baseline MRI visit (may enroll up to 60 days before 6th birthday)
- Confirmed cystic fibrosis diagnosis by sweat chloride test 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 treatment with ivacaftor or combination therapies for gating mutations
- Acute respiratory symptoms such as wheezing at the time of MRI
- Respiratory infection in the 28 days prior to enrollment
- Chronic lung or liver disease not caused by cystic fibrosis
- Acute or chronic pancreatitis unrelated to cystic fibrosis
- Physical conditions that may compromise safety or study data quality
- Any other condition that may prevent informed consent or safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants undergo advanced 129Xe MRI scans to assess lung, liver, and pancreas function before and after starting triple-combination therapy.
1 baseline visit and 1 follow-up visit
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
P
Penny New, BS
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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