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

Solitary Pulmonary Nodule Clinical Trial

Official title:

Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528733
• Other study ID #: KAIGRH1
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2020
• Source: KA Imaging Inc.
• Contact: Tracy Nelson
• Phone: (519) 749-4370
• Email: Tracy.Nelson[@]grhosp.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Tumor
• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

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.

Locations

Country	Name	City	State
Canada	Grand River Hospital	Kitchener	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KA Imaging Inc.	Grand River Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	3 months
Secondary	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)).	3 months