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CompletedNCT02364674TROFIUpdated Mar 29, 2017

Transplant Optimization Using Functional Imaging

An interventional study of High Resolution Computed Tomography scan in Bronchiolitis Obliterans and Lung Transplant Rejection, sponsored by FLUIDDA nv. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by FLUIDDA nv · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bronchiolitis Obliterans
  • Lung Transplant Rejection

Keywords

  • HRCT
  • High Resolution Computed Tomography scans
  • Functional Respiratory Imaging
  • FRI
  • Computed Tomography
  • CT
  • Bronchiolitis Obliterans
  • BOS
  • Lung Transplant
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In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's enrollment of 8 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

FLUIDDA nv is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnant or lactating female
  • Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    HRCT scans

    HRCT scan will be taken

    Radiation: High Resolution Computed Tomography scan

Interventions

  • RadiationHigh 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.

    Also known as: HRCT scan

06

What researchers measure

Primary outcomes

  1. Airway Volume (iVaw)

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  2. Airway Resistance (iRaw)

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  3. Specific Airway Volume (siVaw)

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  4. Specific Airway Resistance (siRaw)

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  5. Lobe volumes (iVlobes)

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  6. Air trapping

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  7. Internal Lobar Airflow Distribution

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  8. Low Attenuation or Emphysema Score

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  9. Blood Vessel Density or Fibrosis Score

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

  10. Airway Wall Thickness

    Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

    Time frame: 12 months

07

Study locations

2 sites
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Hospital of the University of Pennsylvania
    Gibson, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02364674
Lead sponsor
FLUIDDA nv
Responsible party
Sponsor
First posted
Feb 18, 2015
Start date
Feb 2015
Primary completion
Jan 9, 2017
Completion
Jan 9, 2017
Last update
Mar 29, 2017

Study contacts

David Lederer, M.D., M.S.
principal investigator · Columbia University
James Lee, M.D., M.S.
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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