Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)
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ClinicalTrials.gov Identifier: NCT02441413 |
Recruitment Status
:
Completed
First Posted
: May 12, 2015
Last Update Posted
: March 29, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bronchiolitis Obliterans Lung Transplant Rejection | Radiation: High Resolution Computed Tomography scans | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Transplant Optimization Using Functional Imaging (TROFI) |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | November 8, 2016 |
Actual Study Completion Date : | November 8, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: HRCT scans
HRCT scan will be taken
|
Radiation: High Resolution Computed Tomography scans
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. Other Name: HRCT scan
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or lactating female
- Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

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): NCT02441413
Belgium | |
Antwerp University Hospital | |
Edegem, Antwerp, Belgium, 2650 |
Principal Investigator: | Wilfried De Backer, M.D., M.S. | University Hospital of Antwerp |
Responsible Party: | FLUIDDA nv |
ClinicalTrials.gov Identifier: | NCT02441413 History of Changes |
Other Study ID Numbers: |
FLUI-2014-103_BE |
First Posted: | May 12, 2015 Key Record Dates |
Last Update Posted: | March 29, 2017 |
Last Verified: | February 2016 |
Keywords provided by FLUIDDA nv:
HRCT High Resolution Computed Tomography scans Functional Respiratory Imaging FRI Computed Tomography |
CT Bronchiolitis Obliterans Syndrome BOS Lung Transplant |
Additional relevant MeSH terms:
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases |
Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |