Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Imaging and Understanding BOS in Lung Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02316392
First received: December 10, 2014
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

Condition Intervention
Bronchiolitis Obliterans Syndrome
Drug: Hyperpolarized Helium-3 MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging and Understanding BOS in Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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

Enrollment: 6
Study Start Date: December 2014
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02316392

Locations
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Jason Woods, PhD. Cincinnati Children's
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02316392     History of Changes
Other Study ID Numbers: 2014-6004
Study First Received: December 10, 2014
Last Updated: March 8, 2017
Individual Participant Data  
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:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 25, 2017