Bronchiolitis ObliteransTROFI_BENCT02441413
Transplant Optimization Using Functional Imaging (TROFI)
A study testing High Resolution Computed Tomography scans in people with Bronchiolitis Obliterans and Lung Transplant Rejection, run by FLUIDDA nv at 1 site in Belgium.
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 scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to 8 Nov 2016
- 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 screening visit and will continue to use a contraception method during the study
- The patient must be able to perform the lung monitoring at home
- Patients diagnosed with BOS 0, BOS 0-p or BOS 1
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
1 site in 1 country.
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 nmon-rigid image registration methods.
- Being tested
- High Resolution Computed Tomography scans
- Keywords
- HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS, Lung Transplant
- Medical subject headings
- Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Computed Tomography scansRadiation
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 scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Volume (iVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Airway Resistance (iRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Specific Airway Volume (siVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Specific Airway Resistance (siRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Lobe Volumes (iVlobes) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Air Trapping using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Internal Lobar Airflow Distribution using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Low attenuation or Emphysema Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Blood Vessel Density or Fibrosis Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Measured: 12 months
Airway Wall Thickness using FRI
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 posted12 May 2015 (estimated)
- Study startSep 2015
- Primary completion8 Nov 2016
- Study completion8 Nov 2016
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, M.D., M.S., Principal investigator, University Hospital of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441413
- Sponsor's protocol ID
- FLUI-2014-103_BE
- Acronym
- TROFI_BE
- Status last verified
- Feb 2016
- First submitted
- 28 Apr 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 (TROFI)
- ClinicalTrials.gov ID
- NCT02441413
- Acronym / sponsor ID
- TROFI_BE / FLUI-2014-103_BE
- Keywords
- HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 12 May 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 nmon-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 scansHRCT 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 (6 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 screening visit 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 scansAlso: 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) using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Resistance (iRaw) using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Volume (siVaw) using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Resistance (siRaw) using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Lobe Volumes (iVlobes) using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Air Trapping using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Internal Lobar Airflow Distribution using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Low attenuation or Emphysema Score using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Blood Vessel Density or Fibrosis Score using FRI
Time frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Wall Thickness using FRI
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.
Wilfried De Backer, M.D., M.S. principal investigator
University Hospital of Antwerp
1 site 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 scans in people with Bronchiolitis Obliterans and Lung Transplant Rejection, run by FLUIDDA nv at 1 site in Belgium.
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 6 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 1 site in Belgium. 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) using FRI (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.