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Design and Evaluation of Mobile X-ray for Rapid and Accurate Diagnosis of Thoracic Disease

Primary Purpose

Thoracic Diseases

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dual energy and tomosynthesis xray
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Diseases

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT

Exclusion Criteria:

  • unable to consent

Sites / Locations

  • Toronto General Hospital, Department of Medical Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Digital Tomosynthesis

Dual energy

Arm Description

Patient will get tomosynthesis scan

Patient will get dual energy scan

Outcomes

Primary Outcome Measures

Improved detection of maliganancy with modified x-ray

Secondary Outcome Measures

Full Information

First Posted
March 12, 2015
Last Updated
October 23, 2018
Sponsor
University Health Network, Toronto
Collaborators
Carestream Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02391896
Brief Title
Design and Evaluation of Mobile X-ray for Rapid and Accurate Diagnosis of Thoracic Disease
Official Title
Design and Evaluation of Innovative Mobile X-Ray Technology for Rapid and Accurate Diagnosis of Thoracic Disease in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
PI has left UHN. This study is no longer running at UHN.
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Carestream Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. The investigators propose to modify a standard X-ray unit to provide more detailed information of the chest such that a CT scan is not required for all patients.
Detailed Description
Dual-energy (DE) imaging consists of acquiring paired "low" and "high"-energy x-ray images. The use of DE to improve radiological contrast was first described by Jacobson et al in 1958; followed by Mistretta et al and Alvarez and Macovski in the mid-1970s. With the advent of new digital X-ray detectors that provide high dose efficiency and rapid readout of digital X-ray projections, there has been renewed interest in using DE x-ray imaging for lung nodule detection. More recently, portable x-ray detectors have made bedside DE imaging possible. Jabri et. al. presented a portable DE system with novel respiratory and cardiac gating, and Hoggarth et. al. investigated the potential for DE subtraction in improving the visualization of lung tumors while performing image-guided radiotherapy. The investigators group is experienced in investigating DE for lung nodule detection, this theoretical framework was instrumental in optimizing a clinical prototype for high-performance DE chest X-ray. It identified optimal DE image acquisition and decomposition techniques, and validated the approach in comparison to human observer performance. The analysis further demonstrated that - given a high-performance flat plate detector, optimal acquisition and decomposition - DE chest X-ray is possible at the same dose as conventional computer radiography (CR) and digital radiography (DR) chest X-ray, while significantly improving conspicuity of subtle lung nodules by the reduction of overlying background noise. The DE work undertaken by our group is unique in terms of providing a clear theoretical framework for optimizing a clinical prototype for best performance in terms of image quality and patient exposure to ionizing radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Tomosynthesis
Arm Type
Other
Arm Description
Patient will get tomosynthesis scan
Arm Title
Dual energy
Arm Type
Other
Arm Description
Patient will get dual energy scan
Intervention Type
Device
Intervention Name(s)
Dual energy and tomosynthesis xray
Primary Outcome Measure Information:
Title
Improved detection of maliganancy with modified x-ray
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT Exclusion Criteria: unable to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narinder Paul, MD
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, Department of Medical Imaging
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

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Design and Evaluation of Mobile X-ray for Rapid and Accurate Diagnosis of Thoracic Disease

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