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Imaging and Understanding BOS in Lung Transplantation

Imaging and Understanding BOS in Lung Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02316392
Enrollment
6
Registered
2014-12-12
Start date
2014-12-31
Completion date
2017-02-28
Last updated
2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans Syndrome

Keywords

Helium, MRI, Lung transplantation

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.

Interventions

DRUGHyperpolarized 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.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analysis of MRI imaging to detect BOS compared to biopsy3 yearsAnalysis of MRI imaging to detect BOS compared to biopsy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026