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History of Changes for Study: NCT03528733
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesion Detection
Latest version (submitted January 8, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 16, 2018 None (earliest Version on record)
2 November 5, 2018 Recruitment Status, Study Status, Study Identification, Contacts/Locations, Eligibility, Study Design, Conditions and Oversight
3 January 8, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Description
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Study NCT03528733
Submitted Date:  May 16, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: KAIGRH1
Brief Title: Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesion Detection
Official Title: Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesion Detection
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: June 1, 2018
Primary Completion: September 1, 2018 [Anticipated]
Study Completion: November 1, 2018 [Anticipated]
First Submitted: May 4, 2018
First Submitted that
Met QC Criteria:
May 16, 2018
First Posted: May 18, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 16, 2018
Last Update Posted: May 18, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: KA Imaging Inc.
Responsible Party: Sponsor
Collaborators: Grand River Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging platform for lung lesion detection.
Detailed Description:

A feasibility study is proposed to investigate the imaging characteristics captured by a Single Exposure Dual-Energy Subtraction digital radiography with KA Imaging's Multi-energy detector.

The acquisition of Dual-Energy Subtraction radiography will consist of using the Multi-Energy detector integrated into the X-ray system in Grand River Hospital. Patient will receive a Multi-Energy Chest radiography exam on the same day as their routine chest CT exam. Each Multi-Energy radiography exam will consist of one Chest PA image. Duration of each procedure is 60 minutes. The Multi-Energy Detector will generate a General Radiography Image and Dual-Energy Subtracted Images.

Visualization of lung lesions by Multi-Energy detector will be compared to corresponding CT exam and general radiography results. Imaging data will be evaluated qualitatively by radiologists on data collection form to describe the findings on the images. Further comparison between general radiography, Dual-Energy Subtraction radiography and CT will be analyzed to determine the differences of imaging characteristics such as description of image quality and visibility of relevant anatomical structures and anomalies.

Open or close this module Conditions
Conditions: Lung Tumor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 10 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Multi-Energy Detector
Multi-Energy Digital Radiography Detector System
Device: Multi-Energy Digital Radiography Detector System
A Multi-energy digital flat panel detector for Single Exposure Dual-Energy Subtraction radiography is developed to capture x-ray images with improved tissue differentiation. Tissue-selective images can be produced at various tissue levels such as bone and soft tissue to visualize obscured anomalies that are not apparent to General Radiography.
Other Names:
  • Multi-Energy X-ray Detector
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
[ Time Frame: 3 months ]

Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions, as determined. Expert readers will qualitatively evaluate the imaging differences (e.g. motion artifacts, technical defects, ease of anomalies identification, etc) with an evaluation form with a questionnaire grading system (i.e. 1 (severe defect), 2 (moderate defect) to 5 (no defect)).
Secondary Outcome Measures:
1. Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
[ Time Frame: 3 months ]

Multi-Energy images will be compared to standard radiography images for visualizing lung lesions, as determined. Expert readers will qualitatively evaluate the imaging differences (e.g. motion artifacts, technical defects, ease of anomalies identification, etc) with an evaluation form with a questionnaire grading system (i.e. 1 (severe defect), 2 (moderate defect) to 5 (no defect)).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age 18 years and older.
  • Patients with previously diagnosed carcinoma with lung metastases
  • Subject is able to provide informed consent
  • Study participant is scheduled to have a chest CT exam as part of their routine care.
  • Study participant is able to stand and be still during the exams.

Exclusion Criteria:

  • Not able or willing to provide Informed Consent, or consent is withdrawn.
  • Study participant is pregnant
  • Study participant is unable to perform standard radiography exam and CT exam
Open or close this module Contacts/Locations
Central Contact Person: Sara Darko
Telephone: (519) 749-4370 Ext. 5745
Email: sara.darko@grhosp.on.ca
Locations: Canada, Ontario
Grand River Hospital
Kitchener, Ontario, Canada, N2G 1G3
Contact:Contact: Sara Darko 519-749-7370 Ext. 5745 sara.darko@grhosp.on.ca
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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