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

NCT ID: NCT03528733

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Tumor Solitary Pulmonary Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multi-Energy Detector

Multi-Energy Digital Radiography Detector System

Group Type EXPERIMENTAL

Multi-Energy Digital Radiography Detector System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Multi-Energy X-ray Detector

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grand River Hospital

OTHER

Sponsor Role collaborator

KA Imaging Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grand River Hospital

Kitchener, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Tracy Nelson

Role: CONTACT

(519) 749-4370 ext. 5745

Facility Contacts

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Tracy Nelson

Role: primary

519-749-7370 ext. 5745

Other Identifiers

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KAIGRH1

Identifier Type: -

Identifier Source: org_study_id

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