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OpenTrials
Completed

NCT Number: NCT02316392

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.

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Key information

Conditions

Bronchiolitis Obliterans Syndrome Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperpolarized Helium-3 MRI

Drug

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

Primary outcomes

  1. Analysis of MRI imaging to detect BOS compared to biopsy

    Time frame: 3 years

    Analysis of MRI imaging to detect BOS compared to biopsy

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2014
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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