← Back to Search

CF pts on MACT for Cystic Fibrosis

N/A
Recruiting
Led By Jason C Woods, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

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.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing structural and functional lung abnormalities via Xenon MRI
Secondary outcome measures
Assessing patients who have self-withdrawn airway clearance treatment to determine ventilation abnormalities.
Other outcome measures
Change in Xenon Ventilation Defect Process (VDP)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CF pts on MACTExperimental Treatment1 Intervention
Males and females from 12 to 21 years old who have been prescribed Mechanical Airway Clearance Therapy for CF.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,511 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
1,105 Patients Enrolled for Cystic Fibrosis
Jason C Woods, PhDPrincipal InvestigatorCincinnati Children's Hospital Medica Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~53 spots leftby Jan 2028