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Imaging and Understanding BOS in Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 10, 2014
First Posted Date December 12, 2014
Last Update Posted Date March 10, 2017
Study Start Date December 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2014)
Analysis of MRI imaging to detect BOS compared to biopsy [ Time Frame: 3 years ]
Analysis of MRI imaging to detect BOS compared to biopsy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging and Understanding BOS in Lung Transplantation
Official Title Imaging and Understanding BOS in 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biopsies of transplanted and explanted lung tissue
Sampling Method Non-Probability Sample
Study Population Subjects who have had or are scheduled for lung transplant
Condition Bronchiolitis Obliterans Syndrome
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.
Other Name: Hp-He3 MRI
Study Groups/Cohorts Post transplant subjects
Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant
Intervention: Drug: Hyperpolarized Helium-3 MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2017)
6
Original Estimated Enrollment
 (submitted: December 11, 2014)
15
Actual Study Completion Date February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 25 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02316392
Other Study ID Numbers 2014-6004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Not Provided
Investigators
Principal Investigator: Jason Woods, PhD. Cincinnati Children's
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2017