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
NCT number | NCT03528733 |
Other study ID # | KAIGRH1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 22, 2018 |
Est. completion date | June 1, 2021 |
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.
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 Exclusion Criteria: - Not able or willing to provide Informed Consent, or consent is withdrawn.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 |
Country | Name | City | State |
---|---|---|---|
Canada | Grand River Hospital | Kitchener | Ontario |
Lead Sponsor | Collaborator |
---|---|
KA Imaging Inc. | Grand River Hospital |
Canada,
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 |
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