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NCT02316392 Clinical Trial

Imaging and Understanding BOS in Lung Transplantation

Bronchiolitis Obliterans Syndrome Clinical Trial

Official title:
Imaging and Understanding BOS in Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02316392
Other study ID # 2014-6004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2014
Est. completion date February 2017

Study information
Verified date August 2023
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 25 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of MRI imaging to detect BOS compared to biopsy Analysis of MRI imaging to detect BOS compared to biopsy 3 years
See also
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Recruiting NCT03072849 - Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation N/A