Lung TumorNCT03528733
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
A study testing Multi-Energy Digital Radiography Detector System in people with Lung Tumor and Solitary Pulmonary Nodule, run by KA Imaging Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Tumor, Solitary Pulmonary Nodule
- What is being tested?
- Multi-Energy Digital Radiography Detector System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not able or willing to provide Informed Consent, or consent is withdrawn.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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Grand River Hospital
Kitchener, Ontario, N2G 1G3
Tracy Nelson, 519-749-7370 ext. 5745, Tracy.Nelson@grhosp.on.ca
About this study
Official title: Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
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.
Read the detailed 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.
- Conditions
- Lung Tumor, Solitary Pulmonary Nodule
- Being tested
- Multi-Energy Digital Radiography Detector System
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Energy Digital Radiography Detector SystemDevice
Also called Multi-Energy X-ray Detector
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Energy Detector | Experimental | Multi-Energy Digital Radiography Detector System Receives: Device: Multi-Energy Digital Radiography Detector System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 3 months
Secondary outcomes (1)
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)).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start22 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KA Imaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Waterloo Regional Health Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528733
- Sponsor's protocol ID
- KAIGRH1
- Status last verified
- Jan 2020
- First submitted
- 4 May 2018
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
- ClinicalTrials.gov ID
- NCT03528733
- Acronym / sponsor ID
- KAIGRH1
- Conditions
- Lung Tumor, Solitary Pulmonary Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KA Imaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- Waterloo Regional Health Network
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Energy Detector | Experimental | Device: Multi-Energy Digital Radiography Detector SystemMulti-Energy Digital Radiography Detector System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Energy Digital Radiography Detector SystemAlso: Multi-Energy X-ray DetectorA 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. | Device | Multi-Energy Detector |
Primary outcome
Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
Time frame: 3 months
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)).
1 secondary outcome
Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Energy Digital Radiography Detector System in people with Lung Tumor and Solitary Pulmonary Nodule, run by KA Imaging Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy Nelson ((519) 749-4370 ext. 5745, Tracy.Nelson@grhosp.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.