Bronchiolitis ObliteransTROFINCT02364674
Transplant Optimization Using Functional Imaging
A study testing High Resolution Computed Tomography scan in people with Bronchiolitis Obliterans and Lung Transplant Rejection, run by FLUIDDA nv at 2 sites in United States.
Trial summary
The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans, Lung Transplant Rejection
- What is being tested?
- High Resolution Computed Tomography scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to 9 Jan 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥ 18 years old
- Written informed consent obtained
- Patient who had undergone a lung transplant a year ago or more.
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
- The patient must be able to perform the lung monitoring at home.
Who cannot join
- Pregnant or lactating female
- Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Gibson, Pennsylvania, 19104
Columbia University Medical Center
New York, New York, 10032
About this study
The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid image registration methods.
- Being tested
- High Resolution Computed Tomography scan
- Keywords
- HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans, BOS, Lung Transplant
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Computed Tomography scanRadiation
Also called HRCT scan
a HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5.
An Upper Airway (UA) scan will be taken on visit 1.
| Study group | Role | What they receive |
|---|---|---|
| HRCT scans | Experimental | HRCT scan will be taken Receives: Radiation: High Resolution Computed Tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Volume (iVaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Airway Resistance (iRaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Specific Airway Volume (siVaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Specific Airway Resistance (siRaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Lobe volumes (iVlobes)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Air trapping
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Internal Lobar Airflow Distribution
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Low Attenuation or Emphysema Score
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Blood Vessel Density or Fibrosis Score
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Airway Wall Thickness
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion9 Jan 2017
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Lederer, M.D., M.S., Principal investigator, Columbia UniversityJames Lee, M.D., M.S., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364674
- Sponsor's protocol ID
- FLUI-2014-103_USA
- Acronym
- TROFI
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2015
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant Optimization Using Functional Imaging
- ClinicalTrials.gov ID
- NCT02364674
- Acronym / sponsor ID
- TROFI / FLUI-2014-103_USA
- Keywords
- HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans, BOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 18 Feb 2015 (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.
The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid image registration methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRCT scans | Experimental | Radiation: High Resolution Computed Tomography scanHRCT scan will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient ≥ 18 years old
- Written informed consent obtained
- Patient who had undergone a lung transplant a year ago or more.
- Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
- The patient must be able to perform the lung monitoring at home.
Key exclusion criteria (2 listed)
- Pregnant or lactating female
- Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
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 |
|---|---|---|
| High Resolution Computed Tomography scanAlso: HRCT scana HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5. An Upper Airway (UA) scan will be taken on visit 1. | Radiation | HRCT scans |
Primary outcome
Airway Volume (iVaw)
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Resistance (iRaw)
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Volume (siVaw)
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Resistance (siRaw)
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Lobe volumes (iVlobes)
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Air trapping
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Internal Lobar Airflow Distribution
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Low Attenuation or Emphysema Score
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Blood Vessel Density or Fibrosis Score
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Wall Thickness
Time frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
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 29 Mar 2017.
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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.
David Lederer, M.D., M.S. principal investigator
Columbia University
James Lee, M.D., M.S. principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Resolution Computed Tomography scan in people with Bronchiolitis Obliterans and Lung Transplant Rejection, run by FLUIDDA nv at 2 sites 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 5 inclusion and 2 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Airway Volume (iVaw) (time frame: 12 months). The study lists 10 primary outcomes in all. 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 29 Mar 2017.