Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 10, 2020
January 1, 2020
2.2 years
May 4, 2018
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
3 months
Study Arms (1)
Multi-Energy Detector
EXPERIMENTALMulti-Energy Digital Radiography Detector System
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KA Imaging Inc.lead
- Grand River Hospitalcollaborator
Study Sites (1)
Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 18, 2018
Study Start
October 22, 2018
Primary Completion
December 31, 2020
Study Completion
June 1, 2021
Last Updated
January 10, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share