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Transplant Optimization Using Functional Imaging (TROFI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv
ClinicalTrials.gov Identifier:
NCT02364674
First received: February 5, 2015
Last updated: March 28, 2017
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 non-rigid image registration methods.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Transplant Optimization Using Functional Imaging

Resource links provided by NLM:


Further study details as provided by FLUIDDA nv:

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

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

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

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

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

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

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

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

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

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


Enrollment: 8
Study Start Date: February 2015
Study Completion Date: January 9, 2017
Primary Completion Date: January 9, 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 scan

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 visit 1 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
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: NCT02364674

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Gibson, Pennsylvania, United States, 19104
Sponsors and Collaborators
FLUIDDA nv
Investigators
Principal Investigator: David Lederer, M.D., M.S. Columbia University
Principal Investigator: James Lee, M.D., M.S. University of Pennsylvania
  More Information

Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT02364674     History of Changes
Other Study ID Numbers: FLUI-2014-103_USA
Study First Received: February 5, 2015
Last Updated: March 28, 2017

Keywords provided by FLUIDDA nv:
HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
FRI
Computed Tomography
CT
Bronchiolitis Obliterans
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 April 27, 2017