Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03593434 |
|
Recruitment Status :
Completed
First Posted : July 20, 2018
Last Update Posted : March 10, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Cystic Fibrosis | Drug: hyperpolarized Xenon gas |
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.
| Study Type : | Observational |
| Actual 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 |
| Actual Primary Completion Date : | December 30, 2021 |
| Actual Study Completion Date : | December 30, 2021 |
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
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
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 42229 | |
| Principal Investigator: | Jason Woods, PhD | Children's Hospital Medical Center, Cincinnati |
| 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: | March 10, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
|
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Xenon Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |