Hp129 Xenon Imaging and BOS in Lung Transplantation

NCT03603899 | Completed Phase 1 FDA Drug

• 1 other identifier: 2017-4120
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Capture 129Xe and proton MRI Images for clinician assessment

  12 months post transplant

Study Arms (1)

Hp 129Xenon

EXPERIMENTAL

Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.

Drug: Hp 129Xenon

Interventions

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.

Hp 129Xenon

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jason Woods, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: July 27, 2018
• Study Start: September 9, 2020
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: October 7, 2025

Record last verified: 2024-09

Locations

US (1)