Bronchiolitis Obliterans SyndromeNCT02316392
Imaging and Understanding BOS in Lung Transplantation
An observational study of Bronchiolitis Obliterans Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome
- What is being tested?
- Hyperpolarized Helium-3 MRI
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects who have had or are scheduled for lung transplant
Who may be able to join
- Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
- Male or female
- 0 to 25 years of age.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.
Read the 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.
- Conditions
- Bronchiolitis Obliterans Syndrome
- Being tested
- Hyperpolarized Helium-3 MRI
- Keywords
- Helium, MRI, Lung transplantation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Helium-3 MRIDrug
Also called Hp-He3 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.
| Study group | Role | What they receive |
|---|---|---|
| Post transplant subjects | Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant Receives: Drug: Hyperpolarized Helium-3 MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of MRI imaging to detect BOS compared to biopsy
Analysis of MRI imaging to detect BOS compared to biopsy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterans SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Woods, PhD., Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316392
- Sponsor's protocol ID
- 2014-6004
- Status last verified
- Aug 2023
- First submitted
- 10 Dec 2014
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: There is no plan to share IPD with other researchers at this time. If this plan changes, no identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Understanding BOS in Lung Transplantation
- ClinicalTrials.gov ID
- NCT02316392
- Acronym / sponsor ID
- 2014-6004
- Conditions
- Bronchiolitis Obliterans Syndrome
- Keywords
- Helium, MRI, Lung transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post transplant subjects | – | Drug: Hyperpolarized Helium-3 MRIHyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects who have had or are scheduled for lung transplant
Key inclusion criteria (3 listed)
- Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
- Male or female
- 0 to 25 years of age.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Helium-3 MRIAlso: Hp-He3 MRISubjects 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. | Drug | Post transplant subjects |
Primary outcome
Analysis of MRI imaging to detect BOS compared to biopsy
Time frame: 3 years
Analysis of MRI imaging to detect BOS compared to biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided. There is no plan to share IPD with other researchers at this time. If this plan changes, no identifiable information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Woods, PhD. principal investigator
Cincinnati Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterans Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of MRI imaging to detect BOS compared to biopsy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.