Imaging and Understanding BOS in Lung Transplantation

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis Obliterans Syndrome
• Intervention / Treatment: Drug: Hyperpolarized Helium-3 MRI

Detailed Description

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have had or are scheduled for lung transplant

Description

Inclusion Criteria:

• Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
• Male or female
• 0 to 25 years of age.

Exclusion Criteria:

• Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
• Inability to perform 10 second breath hold for 3He MRI scan
• Bleeding disorders

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post transplant subjects; Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant	Drug: Hyperpolarized Helium-3 MRI; Subjects will inhale Hyperpolarized Helium-3 gas during the MRI. This gas enhances images and the data collected will be used to determine if it can be used to detect BOS earlier than current standard of care.; Other Names: Hp-He3 MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of MRI imaging to detect BOS compared to biopsy	Analysis of MRI imaging to detect BOS compared to biopsy	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimated): December 12, 2014

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Lung transplantation; Helium
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Organizing Pneumonia; Graft vs Host Disease; Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: 2014-6004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is no plan to share IPD with other researchers at this time. If this plan changes, no identifiable information will be shared.