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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.
This protocol aims to
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hp 129Xenon | Experimental | Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hp 129Xenon | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Woods, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2017 | Oct 2, 2025 | Prot_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 25, 2026 | Feb 10, 2026 | 11 | ||
| Mar 24, 2026 |
| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| Apr 9, 2026 |
| 12 |
| May 20, 2026 | Jun 15, 2026 | 13 |
| Jun 29, 2026 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |