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Imaging and Understanding BOS in Lung Transplantation

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ClinicalTrials.gov Identifier: NCT02316392
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment
Bronchiolitis Obliterans Syndrome Drug: Hyperpolarized Helium-3 MRI

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.

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging and Understanding BOS in Lung Transplantation
Study Start Date : December 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Post transplant subjects
Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant
 Drug: 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.
Other Name: Hp-He3 MRI


Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Biopsies of transplanted and explanted lung tissue

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have had or are scheduled for lung transplant
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316392


Locations
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United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jason Woods, PhD. Cincinnati Children's
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02316392     History of Changes
Other Study ID Numbers: 2014-6004
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to share IPD with other researchers at this time. If this plan changes, no identifiable information will be shared.
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Helium
MRI
Lung transplantation
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
 Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections