Try our beta test site

Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv
ClinicalTrials.gov Identifier:
NCT02441413
First received: April 28, 2015
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Bronchiolitis Obliterans
Lung Transplant Rejection
Radiation: High Resolution Computed Tomography scans

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Transplant Optimization Using Functional Imaging (TROFI)

Resource links provided by NLM:


Further study details as provided by FLUIDDA nv:

Primary Outcome Measures:
  • Airway Volume (iVaw) using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Airway Resistance (iRaw) using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Specific Airway Volume (siVaw) using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Specific Airway Resistance (siRaw) using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Lobe Volumes (iVlobes) using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Air Trapping using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Internal Lobar Airflow Distribution using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Low attenuation or Emphysema Score using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Blood Vessel Density or Fibrosis Score using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

  • Airway Wall Thickness using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.


Enrollment: 3
Study Start Date: September 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HRCT scans
HRCT scan will be taken
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.

Other Name: HRCT scan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02441413

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FLUIDDA nv
Investigators
Principal Investigator: Wilfried De Backer, M.D., M.S. University Hospital of Antwerp
  More Information

Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT02441413     History of Changes
Other Study ID Numbers: FLUI-2014-103_BE
Study First Received: April 28, 2015
Last Updated: February 23, 2016

Keywords provided by FLUIDDA nv:
HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
FRI
Computed Tomography
CT
Bronchiolitis Obliterans Syndrome
BOS
Lung Transplant

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on March 24, 2017