Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
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|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
|Condition or disease||Intervention/treatment||Phase|
|Lung Tumor Solitary Pulmonary Nodule||Device: Multi-Energy Digital Radiography Detector System||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)).
- 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)).
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
|Contact: Tracy Nelson||(519) 749-4370 ext 5745||Tracy.Nelson@grhosp.on.ca|
|Grand River Hospital||Recruiting|
|Kitchener, Ontario, Canada, N2G 1G3|
|Contact: Tracy Nelson 519-749-7370 ext 5745 Tracy.Nelson@grhosp.on.ca|