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Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02441413
First Posted: May 12, 2015
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
FLUIDDA nv
  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: None (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
Study Completion Date: November 8, 2016
Primary Completion Date: November 8, 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 28, 2015
First Posted: May 12, 2015
Last Update Posted: March 29, 2017
Last Verified: February 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