- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441413
Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)
March 28, 2017 updated by: FLUIDDA nv
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerp
-
Edegem, Antwerp, Belgium, 2650
- Antwerp University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HRCT scans
HRCT scan will be taken
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway Volume (iVaw) using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Airway Resistance (iRaw) using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Specific Airway Volume (siVaw) using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Specific Airway Resistance (siRaw) using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Lobe Volumes (iVlobes) using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Air Trapping using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Internal Lobar Airflow Distribution using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Low attenuation or Emphysema Score using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
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.
|
12 months
|
Airway Wall Thickness using FRI
Time Frame: 12 months
|
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
November 8, 2016
Study Completion (Actual)
November 8, 2016
Study Registration Dates
First Submitted
April 28, 2015
First Submitted That Met QC Criteria
May 7, 2015
First Posted (Estimate)
May 12, 2015
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLUI-2014-103_BE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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