BEGIN Novel ImagiNG Biomarkers
Recruiting
Phase 4
Interventional Study
Cystic Fibrosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 8
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 44 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent (and assent where appropriate) obtained from the subject or subject's legal representative.
2. Willingness to adhere to the study-visit schedule and other protocol requirements.
3. Ages 6-8 years old at baseline MRI visit (may be enrolled up to 60 day…
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