Imaging and Understanding BOS in Lung Transplantation

NCT ID: NCT02316392

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Bronchiolitis Obliterans Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Post transplant subjects

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

Hyperpolarized Helium-3 MRI

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Hp-He3 MRI

Eligibility Criteria

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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

* Inability to perform 10 second breath hold for 3He MRI scan
* Bleeding disorders
Minimum Eligible Age

1 Year

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Woods, PhD.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's

Locations

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Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2014-6004

Identifier Type: -

Identifier Source: org_study_id

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