Skip to main content
Clinical Trials/NCT02316392
NCT02316392
Completed
Not Applicable

Imaging and Understanding BOS in Lung Transplantation

Children's Hospital Medical Center, Cincinnati1 site in 1 country6 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Hyperpolarized Helium-3 MRI
Conditions
Bronchiolitis Obliterans Syndrome
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
6
Locations
1
Primary Endpoint
Analysis of MRI imaging to detect BOS compared to biopsy
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
February 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Post transplant subjects

Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant

Intervention: Hyperpolarized Helium-3 MRI

Outcomes

Primary Outcomes

Analysis of MRI imaging to detect BOS compared to biopsy

Time Frame: 3 years

Analysis of MRI imaging to detect BOS compared to biopsy

Study Sites (1)

Loading locations...

Similar Trials