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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

This study is currently recruiting participants.
Verified October 2017 by FLUIDDA nv
Sponsor:
ClinicalTrials.gov Identifier:
NCT02488304
First Posted: July 2, 2015
Last Update Posted: October 3, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
FLUIDDA nv
  Purpose
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.

Condition Intervention Phase
Bronchiolitis Obliterans Lung Transplant Rejection Radiation: HRCT scans Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Resource links provided by NLM:


Further study details as provided by FLUIDDA nv:

Primary Outcome Measures:
  • Change in Airway Volume (iVaw) using FRI [ Time Frame: 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 [ Time Frame: 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 Volume (siVaw) using FRI [ Time Frame: 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 Specific Airway Resistance (siRaw) using FRI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Low Attenuation or Emphysema Score using FRI [ Time Frame: 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 Blood Vessel Density or Fibrosis Score using FRI [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 10
Study Start Date: July 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HRCT scans
High Resolution Computed Tomography scans will be taken
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.

Other Name: High Resolution Computed Tomography scans

  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
  • 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
  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): NCT02488304


Contacts
Contact: Jan De Backer, MSc, PhD, MBA 003234508720 jan.debacker@fluidda.com
Contact: Caroline Beckers, ir. 0003234508726 caroline.beckers@fluidda.com

Locations
Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Wilfried De Backer, MD, PhD    +32 3 821 34 47    wilfried.de.backer@uza.be   
Principal Investigator: Wilfried De Backer, MD, PhD         
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: NCT02488304     History of Changes
Other Study ID Numbers: FLUI-2015-141
First Submitted: June 26, 2015
First Posted: July 2, 2015
Last Update Posted: October 3, 2017
Last Verified: October 2017

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