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

Primary Purpose

Lung Tumor, Solitary Pulmonary Nodule

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multi-Energy Digital Radiography Detector System
Sponsored by
KA Imaging Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Not able or willing to provide Informed Consent, or consent is withdrawn.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

Sites / Locations

  • Grand River HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-Energy Detector

Arm Description

Multi-Energy Digital Radiography Detector System

Outcomes

Primary Outcome Measures

Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
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

Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
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)).

Full Information

First Posted
May 4, 2018
Last Updated
January 8, 2020
Sponsor
KA Imaging Inc.
Collaborators
Grand River Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03528733
Brief Title
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Official Title
Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KA Imaging Inc.
Collaborators
Grand River Hospital

4. Oversight

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

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Tumor, Solitary Pulmonary Nodule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Energy Detector
Arm Type
Experimental
Arm Description
Multi-Energy Digital Radiography Detector System
Intervention Type
Device
Intervention Name(s)
Multi-Energy Digital Radiography Detector System
Other Intervention Name(s)
Multi-Energy X-ray Detector
Intervention Description
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.
Primary Outcome Measure Information:
Title
Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
Description
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)).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
Description
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)).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Nelson
Phone
(519) 749-4370
Ext
5745
Email
Tracy.Nelson@grhosp.on.ca
Facility Information:
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Nelson
Phone
519-749-7370
Ext
5745
Email
Tracy.Nelson@grhosp.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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