Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT03528733
Status:
UNKNOWN
Last Update Posted:
2020-01-10
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Sponsor:
KA Imaging Inc.
Organization:
Study Overview
Official Title:
Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: