Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Phase 2

Terminated

• Conditions: Lung Transplant Rejection; Bronchiolitis Obliterans
• Interventions: Radiation: HRCT scans

• Registration Number: NCT02488304
• Lead Sponsor: FLUIDDA nv

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-02
• Status Verified: 2017-10
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRCT scans	HRCT scans	High Resolution Computed Tomography scans will be taken

Primary Outcome Measures

Name	Time	Method
Change in Specific Airway Volume (siVaw) using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Lobe Volumes (iVlobes) using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Low Attenuation or Emphysema Score using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Wall Thickness using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Volume (iVaw) using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Resistance (iRaw) using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	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.
Change in Specific Airway Resistance (siRaw) using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Air trapping using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	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.
Change in Internal Lobar Airflow Distribution using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	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).
Change in Blood Vessel Density or Fibrosis Score using FRI	3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant	Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium