Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

NCT02488304 | Terminated Phase 2

• 1 other identifier: FLUI-2015-141
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Obliterans; Lung Transplant Rejection

Keywords

HRCT; High Resolution Computed Tomography scans; Functional Respiratory Imaging; FRI; Computed Tomography; CT; Bronchiolitis Obliterans Syndrome; BOS; Lung Transplant

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

HRCT scans

EXPERIMENTAL

High Resolution Computed Tomography scans will be taken

Radiation: HRCT scans

Interventions

HRCT scans RADIATION

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.

Also known as: High Resolution Computed Tomography scans

HRCT scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating female
• Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Study Officials

• Wilfried De Backer, M.D., M.S.

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: March 21, 2018

Record last verified: 2017-10

Locations

BE (1)