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

Group/Cohort | Intervention/treatment |
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Post transplant subjects
Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant
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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 |
- 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

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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 |
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

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
United States, Ohio | |
Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Jason Woods, PhD. | Cincinnati Children's |
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT02316392 |
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. |
Helium MRI Lung transplantation |
Bronchiolitis Bronchiolitis Obliterans Bronchitis Respiratory Tract Infections Infections |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |