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NCT04259970 · ClinicalTrials.gov registry record · Phase 4
Hyperpolarized Imaging for New Treatments
A Phase 4 study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
- 4
- Study locations
NCT04259970: Active Phase 4 study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04259970 is a Phase 4 study of Cystic Fibrosis that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 64 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (64% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04259970, a Phase 4 study of Cystic Fibrosis, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
- 4
- Study locations
Study Summary
The introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel outcome measures that can detect CF lung disease at an early stage, capture the efficacy of new therapies when disease manifestations are limited, as well as determine whether stopping existing chronic maintenance therapies does not have negative effects. In the past decade, research has focused on the multiple breath washout (MBW) test, as a sensitive outcome measure, especially if highly-effective modulator therapies are initiated in early childhood. Even LCI, however, may not adequately capture early lung function changes, thus warranting investigation of even more sensitive outcome measures. Magnetic resonance imaging (MRI) has the advantage of being a radiation-free modality, making it more suitable for assessing response to therapy in a shorter time frame with repeated imaging. Inhalation of a hyperpolarized gas enables the visualization and quantification of regional ventilation in the lung and can be combined with structural MRI to assess both structure and function in parallel. The main Investigator and others have recently formed an international consortium (the 129Xe MRI Clinical Trial Consortium), comprised of both imaging experts and pulmonary clinicians to standardize imaging procedures, thus facilitating multi-site implementations. Data from this proposed study (HyPOINT; Hyperpolarized Imaging for New Treatments) will inform the future utility of MRI for both longitudinal studies to track disease progression over time as well as for future interventional trials. Further, the current study could inform the design of future trials of interventions of patients for whom currently no effective CFTR modulator therapy is available and for patients with rare genotypes thus laying the groundwork for a more personalized medicine approach
Primary Outcome
The primary analysis will use a paired, non-parametric test (e.g., Wilcoxson Rank sum) to determine if the change in VDP from baseline to 28 days is statistically different from no change in VDP.
Conditions Studied
Interventions
- DRUG Initiation of CFTR Modulator
Study Locations (4)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Virginia
- University of Virginia School of Medicine - Charlottesville
Wisconsin
- University of Wisconsin - Madison
Ontario
- The Hospital for Sick Kids - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What the registry record for NCT04259970 still lists
NCT04259970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Initiation of CFTR Modulator is the first listed.
NCT04259970 reports a single indexed study location in Ohio, Virginia, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04259970 about?
NCT04259970 is a clinical study titled "Hyperpolarized Imaging for New Treatments". The introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel outcome measures that can detect CF lung disease at an early stage, capture ...
What is the current status of trial NCT04259970?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2020-01-13. Estimated completion is 2026-12-31.
What conditions does trial NCT04259970 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT04259970?
The interventions under investigation include: Initiation of CFTR Modulator (DRUG).
Who is sponsoring clinical trial NCT04259970?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04259970 being conducted?
This trial has 4 study locations across Ohio, Virginia, Wisconsin, Ontario. 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 NCT04259970's enrollment target sits among peer trials
64 77th of 169 higher than 93 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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