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NCT02848560 · ClinicalTrials.gov registry record
Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI
A clinical trial of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- 38
- Enrollment target
- 1
- Study location
NCT02848560: Active study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02848560 is a study of Cystic Fibrosis that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 38 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02848560, a study of Cystic Fibrosis, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational study for children with Cystic Fibrosis (CF) who are eligible based on their CF gene type. One group will be called the treatment group because they have the gene type (homozygous F508del) that makes them clinically eligible through their CF care provider to begin treatment with the new FDA approved CF drug called orkambi. For the control group, children will be enrolled who have a similar CF gene type (heterozygous F508del) but are not eligible to be prescribed orkambi. The two groups will be followed for four visits over about 3 to 4 years to observe changes in the lungs. Methods to measure the changes in lung disease will include: MRI with non-FDA approved inhaled xenon gas to take detailed images of the lungs, Pulmonary Function Tests (PFT), Lung Clearance Index (LCI), Baseline CT image of the lungs if not ordered as part of usual clinical care. The first two visits will be done before starting clinical treatment with orkambi and will be a minimum of 28 days apart and up to 18 months. The third visit will be scheduled about 3 months after starting orkambi and the fourth visit about 18 months later. For the control group, the timing of visits will be similar to treatment group and visits may be scheduled around annual CF care visits.
Primary Outcome
Lung defect calculations (total and lobar defect percentages) will be performed by evaluating the percentage of voxels with signals below a threshold value of 60% of the total lung mean signal.
Conditions Studied
Interventions
- DRUG Hyperpolarized Xenon
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-03 |
| Est. Completion | 2025-10-31 |
What the registry record for NCT02848560 still lists
NCT02848560 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Hyperpolarized Xenon is the first listed.
NCT02848560 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02848560 about?
NCT02848560 is a clinical study titled "Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI". This is an observational study for children with Cystic Fibrosis (CF) who are eligible based on their CF gene type. One group will be called the treatment group because they have the gene type (homozygous F508del) that makes them clinically eligible through their CF care provider to begin treatment ...
What is the current status of trial NCT02848560?
This trial is currently active not recruiting. The enrollment target is 38 participants. The study started on 2016-03. Estimated completion is 2025-10-31.
What conditions does trial NCT02848560 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02848560?
The interventions under investigation include: Hyperpolarized Xenon (DRUG).
Who is sponsoring clinical trial NCT02848560?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02848560 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02848560's enrollment target sits among peer trials
38 106th of 169 higher than 64 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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