Bronchiolitis ObliteransPhase 2NCT02488304
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
A Phase 2 study testing HRCT 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 BOS in an early stage by 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… 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?
- HRCT scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to 15 Dec 2017
- Phase
- Phase 2
- 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
- Patients who are planned to receive a lung transplant in the near future
- 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
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 BOS in an early stage by 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 rejection over time will be monitored using non-rigid image registration methods.
- Being tested
- HRCT 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.
HRCT scansRadiation
Also called High Resolution Computed Tomography scans
A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7.
An upper airway (UA) scan will be taken on visit 2.
| Study group | Role | What they receive |
|---|---|---|
| HRCT scans | Experimental | High Resolution Computed Tomography scans will be taken Receives: Radiation: HRCT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Airway Volume (iVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Airway Resistance (iRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Specific Airway Volume (siVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Specific Airway Resistance (siRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Lobe Volumes (iVlobes) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Air trapping using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than -850 HU at functional residual capacity.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Internal Lobar Airflow Distribution using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe [%] = 100 (VTLC_lobe - VFRC_lobe) / (VTLC_lungs - VFRC_lungs).
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Low Attenuation or Emphysema Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Blood Vessel Density or Fibrosis Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Airway Wall Thickness using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Measured: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Why it stopped: the lung transplantation program at the site is on hold
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT02488304
- Sponsor's protocol ID
- FLUI-2015-141
- Status last verified
- Oct 2017
- First submitted
- 26 Jun 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
- ClinicalTrials.gov ID
- NCT02488304
- Acronym / sponsor ID
- FLUI-2015-141
- Keywords
- HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the lung transplantation program at the site is on hold
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 Jul 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 BOS in an early stage by 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 rejection 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: HRCT scansHigh Resolution Computed Tomography scans 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
- Patients who are planned to receive a lung transplant in the near future
- 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 |
|---|---|---|
| HRCT scansAlso: High Resolution Computed Tomography scansA HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7. An upper airway (UA) scan will be taken on visit 2. | Radiation | HRCT scans |
Primary outcome
Change in Airway Volume (iVaw) using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Resistance (iRaw) using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.
Change in Specific Airway Volume (siVaw) using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Specific Airway Resistance (siRaw) using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Lobe Volumes (iVlobes) using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Air trapping using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than -850 HU at functional residual capacity.
Change in Internal Lobar Airflow Distribution using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe [%] = 100 (VTLC_lobe - VFRC_lobe) / (VTLC_lungs - VFRC_lungs).
Change in Low Attenuation or Emphysema Score using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Blood Vessel Density or Fibrosis Score using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Wall Thickness using FRI
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Results and safety
The study was stopped early (reason given: the lung transplantation program at the site is on hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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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 Phase 2 study testing HRCT 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 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: stopped early, as of the sponsor's last update on 21 Mar 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the lung transplantation program at the site is on hold). Results are not available in the source record.
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?
Change in Airway Volume (iVaw) using FRI (time frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant). 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 21 Mar 2018.