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NCT06339593 · ClinicalTrials.gov registry record · Early Phase 1
Regional Monitoring of CF Lung Disease
A Early Phase 1 study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06339593 is a Early Phase 1 study of Cystic Fibrosis that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 60 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06339593, a Early Phase 1 study of Cystic Fibrosis, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.
Conditions Studied
Interventions
- DRUG Hyperpolarized Xe129
- PROCEDURE Airway-clearance vest
Study Locations (1)
Ohio
- Cincinnati Children's Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2028-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06339593
The ClinicalTrials.gov registry entry for NCT06339593 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (66% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Hyperpolarized Xe129 is the first listed.
NCT06339593 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06339593 about?
NCT06339593 is a clinical study titled "Regional Monitoring of CF Lung Disease". The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. Th...
What is the current status of trial NCT06339593?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2024-01-05. Estimated completion is 2028-01.
What conditions does trial NCT06339593 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT06339593?
The interventions under investigation include: Hyperpolarized Xe129 (DRUG), Airway-clearance vest (PROCEDURE).
Who is sponsoring clinical trial NCT06339593?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06339593 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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