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Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)
This study has been completed.
Sponsor:
FLUIDDA nv
Information provided by (Responsible Party):
FLUIDDA nv
ClinicalTrials.gov Identifier:
NCT02441413
First received: April 28, 2015
Last updated: March 28, 2017
Last verified: February 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Bronchiolitis Obliterans Lung Transplant Rejection | Radiation: High Resolution Computed Tomography scans |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Transplant Optimization Using Functional Imaging (TROFI) |
Resource links provided by NLM:
Further study details as provided by FLUIDDA nv:
Primary Outcome Measures:
- 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.
| Enrollment: | 3 |
| Study Start Date: | September 2015 |
| Study Completion Date: | November 8, 2016 |
| Primary Completion Date: | November 8, 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02441413
Please refer to this study by its ClinicalTrials.gov identifier: NCT02441413
Locations
| Belgium | |
| Antwerp University Hospital | |
| Edegem, Antwerp, Belgium, 2650 | |
Sponsors and Collaborators
FLUIDDA nv
Investigators
| Principal Investigator: | Wilfried De Backer, M.D., M.S. | University Hospital of Antwerp |
More Information
| Responsible Party: | FLUIDDA nv |
| ClinicalTrials.gov Identifier: | NCT02441413 History of Changes |
| Other Study ID Numbers: |
FLUI-2014-103_BE |
| Study First Received: | April 28, 2015 |
| Last Updated: | March 28, 2017 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017