Hp129 Xenon Imaging and BOS in Lung Transplantation

Cincinnati Children's Hospital Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Bronchiolitis Obliterans

Treatments

Drug: Hp 129Xenon

Study type

Interventional

Funder types

Other

Identifiers

NCT03603899

2017-4120

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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.