Hp129 Xenon Imaging and BOS in Lung Transplantation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 2/3/2019 |
| Start Date: | June 2019 |
| End Date: | July 2021 |
| Contact: | Erin Watters |
| Email: | Erin.Watters@cchmc.org |
| Phone: | 513-803-7024 |
Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging
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.
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
- 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.
- 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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-803-4463
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Click here to add this to my saved trials
