Hp129 Xenon Imaging and BOS in Lung Transplantation
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|ClinicalTrials.gov Identifier: NCT03603899|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans||Drug: Hp 129Xenon||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2027|
|Estimated Study Completion Date :||September 2028|
Experimental: Hp 129Xenon
Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.
Drug: Hp 129Xenon
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.
- Capture 129Xe and proton MRI Images for clinician assessment [ Time Frame: 6 months post transplant ]Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
- Capture 129Xe and proton MRI Images for clinician assessment [ Time Frame: 12 months post transplant ]Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits
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): NCT03603899
|Contact: Erin Watters||513-803-7024||Erin.Watters@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Jason Woods, PhD 513-803-4463 firstname.lastname@example.org|
|Principal Investigator:||Jason Woods, PhD||Children's Hospital Medical Center, Cincinnati|