Recruiting

Observational Study

Sponsor:

KA Imaging Inc.

Code:

NCT03528733

Conditions

Lung Tumor

Solitary Pulmonary Nodule

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multi-Energy Digital Radiography Detector System

Study Details

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.

Conditions

Lung Tumor

Solitary Pulmonary Nodule

Study ID

NCT03528733

Start date

Oct 22, 2018

Status verified date

Jan, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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  • Not able or willing to provide Informed Consent, or consent is withdrawn.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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Multi-Energy Detector

Multi-Energy Digital Radiography Detector System

Interventions

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.

Primary outcome measure

  • Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions. [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Tracy Nelson

(519) 749-4370Tracy.Nelson@grhosp.on.ca

Locations

Grand River Hospital

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Tracy Nelson

519-749-7370Tracy.Nelson@grhosp.on.ca

More Information

Sponsor

KA Imaging Inc.

Last update posted

Jan 10, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by KA Imaging Inc. on 2020-01-10.