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出境医 / 临床实验 / Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection

Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection

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.

Condition or disease Intervention/treatment Phase
Lung Tumor Solitary Pulmonary Nodule Device: Multi-Energy Digital Radiography Detector System Not Applicable

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 and one Chest LAT 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
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 Name: Multi-Energy X-ray Detector
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)).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older.
  • Patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule
  • 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
Contacts and Locations

Contacts
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Contact: Tracy Nelson (519) 749-4370 ext 5745 Tracy.Nelson@grhosp.on.ca

Locations
Layout table for location information
Canada, Ontario
Grand River Hospital Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Tracy Nelson    519-749-7370 ext 5745    Tracy.Nelson@grhosp.on.ca   
Sponsors and Collaborators
KA Imaging Inc.
Grand River Hospital
Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date January 10, 2020
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018) 		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)).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018) 		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)).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Official Title  ICMJE Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
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 and one Chest LAT 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lung Tumor
  • Solitary Pulmonary Nodule
Intervention  ICMJE 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 Name: Multi-Energy X-ray Detector
Study Arms  ICMJE Experimental: Multi-Energy Detector
Multi-Energy Digital Radiography Detector System
Intervention: Device: Multi-Energy Digital Radiography Detector System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2018) 		30
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2018) 		10
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years and older.
  • Patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tracy Nelson (519) 749-4370 ext 5745 Tracy.Nelson@grhosp.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528733
Other Study ID Numbers  ICMJE KAIGRH1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party KA Imaging Inc.
Study Sponsor  ICMJE KA Imaging Inc.
Collaborators  ICMJE Grand River Hospital
Investigators  ICMJE Not Provided
PRS Account KA Imaging Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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