Hp129 Xenon Imaging and BOS in Lung Transplantation
Primary Purpose
Bronchiolitis Obliterans
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hp 129Xenon
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchiolitis Obliterans
Eligibility Criteria
Inclusion Criteria:
- Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
- Participant must be able to hold their breath for up to 16 seconds.
Exclusion Criteria:
- Standard MRI exclusion criteria
- Bleeding disorders
- Participant is claustrophobic or otherwise unable to tolerate the imaging
- Pregnancy or positive pregnancy test
- Symptoms of respiratory infection within the past two weeks.
- Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hp 129Xenon
Arm Description
Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.
Outcomes
Primary Outcome Measures
Capture 129Xe and proton MRI Images for clinician assessment
Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
Secondary Outcome Measures
Capture 129Xe and proton MRI Images for clinician assessment
Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
Full Information
NCT ID
NCT03603899
First Posted
October 4, 2017
Last Updated
August 21, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03603899
Brief Title
Hp129 Xenon Imaging and BOS in Lung Transplantation
Official Title
Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. Although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung. Biopsies may be used for future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.
Detailed Description
This protocol aims to
Develop new imaging methods that are sufficiently sensitive to allow early diagnosis of BOS.
Improve patient treatment outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided biopsies of transplanted lung.
Provide image guided biopsies for use in future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.
The study will achieve these aims through a prospective, non-randomized, longitudinal, observational study that will recruit about 5 subjects a year for 5 years. The study will follow these post lung transplant patients at 6 months and 1 year with 129Xe MRI (Hyperpolarized 129Xenon Magnetic Resonance Imaging) and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hp 129Xenon
Arm Type
Experimental
Arm Description
Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.
Intervention Type
Drug
Intervention Name(s)
Hp 129Xenon
Intervention Description
129 Xenon is a noble gas with no taste or smell. It will be made slightly magnetic (also called hyperpolarizing) and then inhaled into the lungs to provide better pictures of the lungs during MRI.
Primary Outcome Measure Information:
Title
Capture 129Xe and proton MRI Images for clinician assessment
Description
Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
Time Frame
6 months post transplant
Secondary Outcome Measure Information:
Title
Capture 129Xe and proton MRI Images for clinician assessment
Description
Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
Time Frame
12 months post transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
Participant must be able to hold their breath for up to 16 seconds.
Exclusion Criteria:
Standard MRI exclusion criteria
Bleeding disorders
Participant is claustrophobic or otherwise unable to tolerate the imaging
Pregnancy or positive pregnancy test
Symptoms of respiratory infection within the past two weeks.
Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Stevens, BS
Phone
(513) 636-9973
Email
carrie.stevens@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Schmitt, RN
Phone
(513) 636-9348
Email
Megan.Schmitt@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Woods, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Woods, PhD
Phone
513-803-4463
Email
jason.woods@cchmc.org
12. IPD Sharing Statement
Learn more about this trial
Hp129 Xenon Imaging and BOS in Lung Transplantation
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