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

K

KA Imaging

Status

Unknown

Conditions

Solitary Pulmonary Nodule
Lung Tumor

Treatments

Device: Multi-Energy Digital Radiography Detector System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03528733
KAIGRH1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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  • Not able or willing to provide Informed Consent, or consent is withdrawn.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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Multi-Energy Detector
Experimental group
Description:
Multi-Energy Digital Radiography Detector System
Treatment:
Device: Multi-Energy Digital Radiography Detector System

Trial contacts and locations

1

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Central trial contact

Tracy Nelson

Data sourced from clinicaltrials.gov

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