Transplant Optimization Using Functional Imaging (TROFI)

Bronchiolitis Obliterans Clinical Trial

— TROFI_BE  

Official title:

Transplant Optimization Using Functional Imaging (TROFI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441413
• Other study ID #: FLUI-2014-103_BE
• 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
• 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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Lung Transplant Rejection

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