NCT02364674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2017

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

February 5, 2015

Last Update Submit

March 28, 2017

Conditions

Bronchiolitis ObliteransLung Transplant Rejection

Keywords

HRCTHigh Resolution Computed Tomography scansFunctional Respiratory ImagingFRIComputed TomographyCTBronchiolitis ObliteransBOSLung Transplant

Outcome Measures

Primary Outcomes (10)

  • Airway Volume (iVaw)

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

    12 months

  • Airway Resistance (iRaw)

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

    12 months

  • Specific Airway Volume (siVaw)

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

    12 months

  • Specific Airway Resistance (siRaw)

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

    12 months

  • Lobe volumes (iVlobes)

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

    12 months

  • Air trapping

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

    12 months

  • Internal Lobar Airflow Distribution

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

    12 months

  • Low Attenuation or Emphysema Score

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

    12 months

  • Blood Vessel Density or Fibrosis Score

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

    12 months

  • Airway Wall Thickness

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

    12 months

Study Arms (1)

HRCT scans

EXPERIMENTAL

HRCT scan will be taken

Radiation: High Resolution Computed Tomography scan

Interventions

High Resolution Computed Tomography scanRADIATION

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
HRCT scans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Hospital of the University of Pennsylvania

Gibson, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • David Lederer, M.D., M.S.

    Columbia University

    PRINCIPAL INVESTIGATOR

  • James Lee, M.D., M.S.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 18, 2015

Study Start

February 1, 2015

Primary Completion

January 9, 2017

Study Completion

January 9, 2017

Last Updated

March 29, 2017

Record last verified: 2016-02

Locations

US(2)