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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528733
Recruitment Status : Unknown
Verified January 2020 by KA Imaging Inc..
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
Grand River Hospital
Information provided by (Responsible Party):
KA Imaging Inc.

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arms and Interventions
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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
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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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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528733


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

Locations
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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
More Information
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Responsible Party: KA Imaging Inc.
ClinicalTrials.gov Identifier: NCT03528733    
Other Study ID Numbers: KAIGRH1
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases