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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT02391896
Collaborator
Carestream Health, Inc. (Industry)
34
1
2
21.1
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dual energy and tomosynthesis xray
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Design and Evaluation of Innovative Mobile X-Ray Technology for Rapid and Accurate Diagnosis of Thoracic Disease in Critically Ill Patients
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Digital Tomosynthesis

Patient will get tomosynthesis scan

Device: Dual energy and tomosynthesis xray

Other: Dual energy

Patient will get dual energy scan

Device: Dual energy and tomosynthesis xray

Outcome Measures

Primary Outcome Measures

  1. Improved detection of maliganancy with modified x-ray [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto General Hospital, Department of Medical Imaging Toronto Ontario Canada M5G 2N2

Sponsors and Collaborators

  • University Health Network, Toronto
  • Carestream Health, Inc.

Investigators

  • Principal Investigator: Narinder Paul, MD, UHN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02391896
Other Study ID Numbers:
  • 14-7549-CE
First Posted:
Mar 18, 2015
Last Update Posted:
Oct 25, 2018
Last Verified:
Oct 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2018