Imaging and Understanding BOS in Lung Transplantation

NCTId: NCT02316392

Official Title

Imaging and Understanding BOS in Lung Transplantation

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 1 Year 25 Years False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

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.

Device Intervention(s)

MRI

Study Outcomes

Primary Outcome(s)

Timeframe: 3 years
Measure: Analysis of MRI imaging to detect BOS compared to biopsy
Description: Analysis of MRI imaging to detect BOS compared to biopsy
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

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

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Bronchiolitis Obliterans Syndrome

Other Related Condition Keywords

  1. Bronchiolitis
  2. Bronchiolitis Obliterans

Related Bronchiolitis Obliterans Syndrome Research

  1. Azithromycin in Bronchiolitis Obliterans Syndrome
  2. Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation