Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Bronchiolitis Obliterans Clinical Trial

Official title:

Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488304
• Other study ID #: FLUI-2015-141
• Status: Terminated
• Phase: Phase 2
• First received: June 26, 2015
• Last updated: March 19, 2018
• Start date: July 2015
• Est. completion date: December 15, 2017

Study information

• Verified date: October 2017
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to detect BOS in an early stage by 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 rejection over time will be monitored using non-rigid image registration methods.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• 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

• Patients who are planned to receive a lung transplant in the near future

• 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

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:
• HRCT scans
A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7. An upper airway (UA) scan will be taken on visit 2.

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	Change in Airway Volume (iVaw) using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Airway Resistance (iRaw) using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Specific Airway Volume (siVaw) using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Specific Airway Resistance (siRaw) using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Lobe Volumes (iVlobes) using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Air trapping using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than -850 HU at functional residual capacity.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Internal Lobar Airflow Distribution using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe [%] = 100 (VTLC_lobe - VFRC_lobe) / (VTLC_lungs - VFRC_lungs).	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Low Attenuation or Emphysema Score using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Blood Vessel Density or Fibrosis Score using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Primary	Change in Airway Wall Thickness using FRI	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant