Clincosm LogoSign in Get a demo

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

Sponsor
KA Imaging Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03528733
Collaborator
Grand River Hospital (Other)
30
Enrollment
1
Location
1
Arm
31.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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
  • Device: Multi-Energy Digital Radiography Detector System
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Oct 22, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Jun 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 Names:
  • 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. [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. [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

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Grand River Hospital Kitchener Ontario Canada N2G 1G3

    Sponsors and Collaborators

    • KA Imaging Inc.
    • Grand River Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KA Imaging Inc.
    ClinicalTrials.gov Identifier:
    NCT03528733
    Other Study ID Numbers:
    • KAIGRH1
    First Posted:
    May 18, 2018
    Last Update Posted:
    Jan 10, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Multiple Pulmonary Nodules
    Solitary Pulmonary Nodule

    Study Results

    No Results Posted as of Jan 10, 2020