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Trial record 2 of 3 for:    cincinnati lung ute | Recruiting Studies

Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI

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ClinicalTrials.gov Identifier: NCT03593434
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jason Woods, Children's Hospital Medical Center, Cincinnati

Brief Summary:
This is an observational cohort study building on an existing protocol at our institution recruiting CF patients who are 6-21 years old with one or two copies of the F508del CFTR mutation. That existing protocol seeks to enroll a total of 38 subjects; it includes three to four (three scheduled, with a fourth optional) study visits, with spirometry, LCI, UTE MRI, and 129Xe MRI being performed at each visit. This present study will utilize existing study visits for the NHLBI study, with a sub-set of 20 subjects opting-in to have all of the procedures performed twice, with an intervening ACT, during one of their study visits.

Condition or disease Intervention/treatment
Cystic Fibrosis Drug: hyperpolarized Xenon gas

Detailed Description:

This is an observational cohort study building on an existing protocol at our institution recruiting CF patients who are 6-21 years old with one or two copies of the F508del CFTR mutation. The existing protocol is funded by the NHLBI under R01-11863962 (PIs Woods, Clancy, and hereafter referred to as "the NHLBI study" for simplicity), and seeks to enroll a total of 38 subjects; it includes three to four (three scheduled, with a fourth optional) study visits, with spirometry, LCI, UTE MRI, and 129Xe MRI being performed at each visit. This present study will utilize existing study visits for the NHLBI study, with patients opting-in to have all of the procedures performed twice, with an intervening ACT, during one their study visits. The target enrollment is 20 subjects.

Airway clearance therapy (ACT) is used for treating cystic fibrosis (CF). It is known to impact measures of lung function, and while an increasing number of lung function measures are used in clinical trials, there has been no direct comparison of the effects of ACT across the different modalities. This study is actively investigating the relationship between different measures of lung function, comparing a spirometric measure (FEV1 percent-predicted) with measures of whole-lung ventilation (lung clearance index, or LCI) and regional assessments of both structure (with ultra-short echo time magnetic resonance imaging, or UTE MRI) and function (with hyperpolarized xenon, or 129Xe, MRI). Performing these assessments on CF patients will help to elucidate the relative sensitivity of each measure to intra-individual changes within the lung and will help guide the selection of lung function measures in future studies.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic Fibrosis
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Xenon


Intervention Details:
  • Drug: hyperpolarized Xenon gas
    This present study will utilize existing study visits for the NHLBI study, with patients opting-in to have all of the procedures performed twice, with an intervening ACT, during one their study visits.
    Other Name: 129Xenon


Primary Outcome Measures :
  1. Effect of ACT on 129Xe MRI [ Time Frame: one-day single study visit ]
    Quantify the effect of ACT on 129Xe MRI in ventilation defect percentage (%), in 20 children ages 6-21 years with CF


Secondary Outcome Measures :
  1. Effect of ACT on spirometry [ Time Frame: one-day single study visit ]
    Quantify the effect of ACT on spirometry in indexed values of FEV1, in percentage (%), in 20 children ages 6-21 years with CF

  2. Effect of ACT on LCI [ Time Frame: one-day single study visit ]
    Quantify the effect of ACT on lung clearance index (LCI) in LCI2.5 values, in 20 children ages 6-21 years with CF


Other Outcome Measures:
  1. Structural changes on UTE MRI [ Time Frame: one-day single study visit ]
    Describe the structural changes on UTE MRI that occur with airway clearance and correlate these with changes in spirometry and measures of ventilation heterogeneity



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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male or female ages 6 through 21 with CF
Criteria

Inclusion Criteria:

  • Male or female between the ages of 6 through 21 years
  • CFTR genotypes as specified in NHLBI study:

Two copies of the F508del CFTR mutation, OR Two non-functional CFTR mutations with one of them being F508del CFTR mutation

• Able to perform acceptable and repeatable spirometry

Exclusion Criteria:

  • FEV1 percent predicted of <60%
  • standard MRI exclusions (metal implants, claustrophobia)
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593434


Contacts
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Contact: Emily Bell, RN 513-803-7429 Emily.Bell@cchmc.org
Contact: Kelly Thornton, CRC 513-636-0604 Kelly.Thornton@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 42229
Contact: Kelly Thornton, BS    513-636-0604    Kelly.Thornton@cchmc.org   
Contact: Emily Bell, RN    (513) 803-7429    Emily.Bell@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jason Woods, PhD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Jason Woods, PhD, Director, Center for Pulmonary Medicine Imaging Research, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03593434    
Other Study ID Numbers: ACT and Xe MRI
1R01HL131012-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lung Diseases
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs