Hp129 Xenon Imaging and BOS in Lung Transplantation

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03603899
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84.7
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Drug: Hp 129Xenon	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging
• Actual Study Start Date: Sep 9, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Capture 129Xe and proton MRI Images for clinician assessment [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

Secondary Outcome Measures

1. Capture 129Xe and proton MRI Images for clinician assessment [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Jason Woods, PhD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT03603899
• Other Study ID Numbers: 2017-4120
• First Posted: Jul 27, 2018
• Last Update Posted: Dec 19, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Xenon

Study Results

No Results Posted as of Dec 19, 2020