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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02441413
Other study ID # FLUI-2014-103_BE
Secondary ID
Status Completed
Phase N/A
First received April 28, 2015
Last updated March 28, 2017
Start date September 2015
Est. completion date November 8, 2016

Study information

Verified date February 2016
Source FLUIDDA nv
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date November 8, 2016
Est. primary completion date November 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Belgium Antwerp University Hospital Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
FLUIDDA nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Airway Volume (iVaw) using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Airway Resistance (iRaw) using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Specific Airway Volume (siVaw) using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Specific Airway Resistance (siRaw) using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Lobe Volumes (iVlobes) using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Air Trapping using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Internal Lobar Airflow Distribution using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Low attenuation or Emphysema Score using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Blood Vessel Density or Fibrosis Score using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
Primary Airway Wall Thickness using FRI Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. 12 months
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