Thoracic DiseasesNCT02391896
Design and Evaluation of Mobile X-ray for Rapid and Accurate Diagnosis of Thoracic Disease
A study testing Dual energy and tomosynthesis xray in people with Thoracic Diseases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thoracic Diseases
- What is being tested?
- Dual energy and tomosynthesis xray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Dec 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT
Who cannot join
- unable to consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, Department of Medical Imaging
Toronto, Ontario, M5G 2N2
About this study
Official title: Design and Evaluation of Innovative Mobile X-Ray Technology for Rapid and Accurate Diagnosis of Thoracic Disease in Critically Ill Patients
Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. The investigators propose to modify a standard X-ray unit to provide more detailed information of the chest such that a CT scan is not required for all patients.
Read the detailed description
Dual-energy (DE) imaging consists of acquiring paired "low" and "high"-energy x-ray images. The use of DE to improve radiological contrast was first described by Jacobson et al in 1958; followed by Mistretta et al and Alvarez and Macovski in the mid-1970s. With the advent of new digital X-ray detectors that provide high dose efficiency and rapid readout of digital X-ray projections, there has been renewed interest in using DE x-ray imaging for lung nodule detection. More recently, portable x-ray detectors have made bedside DE imaging possible. Jabri et. al. presented a portable DE system with novel respiratory and cardiac gating, and Hoggarth et. al. investigated the potential for DE subtraction in improving the visualization of lung tumors while performing image-guided radiotherapy.
The investigators group is experienced in investigating DE for lung nodule detection, this theoretical framework was instrumental in optimizing a clinical prototype for high-performance DE chest X-ray. It identified optimal DE image acquisition and decomposition techniques, and validated the approach in comparison to human observer performance. The analysis further demonstrated that - given a high-performance flat plate detector, optimal acquisition and decomposition - DE chest X-ray is possible at the same dose as conventional computer radiography (CR) and digital radiography (DR) chest X-ray, while significantly improving conspicuity of subtle lung nodules by the reduction of overlying background noise. The DE work undertaken by our group is unique in terms of providing a clear theoretical framework for optimizing a clinical prototype for best performance in terms of image quality and patient exposure to ionizing radiation.
- Conditions
- Thoracic Diseases
- Being tested
- Dual energy and tomosynthesis xray
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual energy and tomosynthesis xrayDevice
| Study group | Role | What they receive |
|---|---|---|
| Digital Tomosynthesis | Other | Patient will get tomosynthesis scan Receives: Device: Dual energy and tomosynthesis xray |
| Dual energy | Other | Patient will get dual energy scan Receives: Device: Dual energy and tomosynthesis xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved detection of maliganancy with modified x-ray
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: PI has left UHN. This study is no longer running at UHN.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Carestream Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Narinder Paul, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391896
- Sponsor's protocol ID
- 14-7549-CE
- Status last verified
- Oct 2018
- First submitted
- 12 Mar 2015
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of Innovative Mobile X-Ray Technology for Rapid and Accurate Diagnosis of Thoracic Disease in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02391896
- Acronym / sponsor ID
- 14-7549-CE
- Conditions
- Thoracic Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left UHN. This study is no longer running at UHN.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Carestream Health, Inc.
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Mar 2015 (estimated)
- 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.
Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. The investigators propose to modify a standard X-ray unit to provide more detailed information of the chest such that a CT scan is not required for all patients.
Detailed description
Dual-energy (DE) imaging consists of acquiring paired "low" and "high"-energy x-ray images. The use of DE to improve radiological contrast was first described by Jacobson et al in 1958; followed by Mistretta et al and Alvarez and Macovski in the mid-1970s. With the advent of new digital X-ray detectors that provide high dose efficiency and rapid readout of digital X-ray projections, there has been renewed interest in using DE x-ray imaging for lung nodule detection. More recently, portable x-ray detectors have made bedside DE imaging possible. Jabri et. al. presented a portable DE system with novel respiratory and cardiac gating, and Hoggarth et. al. investigated the potential for DE subtraction in improving the visualization of lung tumors while performing image-guided radiotherapy.
The investigators group is experienced in investigating DE for lung nodule detection, this theoretical framework was instrumental in optimizing a clinical prototype for high-performance DE chest X-ray. It identified optimal DE image acquisition and decomposition techniques, and validated the approach in comparison to human observer performance. The analysis further demonstrated that - given a high-performance flat plate detector, optimal acquisition and decomposition - DE chest X-ray is possible at the same dose as conventional computer radiography (CR) and digital radiography (DR) chest X-ray, while significantly improving conspicuity of subtle lung nodules by the reduction of overlying background noise. The DE work undertaken by our group is unique in terms of providing a clear theoretical framework for optimizing a clinical prototype for best performance in terms of image quality and patient exposure to ionizing radiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Tomosynthesis | Other | Device: Dual energy and tomosynthesis xrayPatient will get tomosynthesis scan |
| Dual energy | Other | Device: Dual energy and tomosynthesis xrayPatient will get dual energy scan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT
Key exclusion criteria (1 listed)
- unable to consent
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 |
|---|---|---|
| Dual energy and tomosynthesis xray | Device | Digital Tomosynthesis, Dual energy |
Primary outcome
Improved detection of maliganancy with modified x-ray
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI has left UHN. This study is no longer running at UHN.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
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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.
Narinder Paul, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual energy and tomosynthesis xray in people with Thoracic Diseases, run by University Health Network, Toronto 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Oct 2018. 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?
The study was stopped early (reason given: PI has left UHN. This study is no longer running at UHN.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved detection of maliganancy with modified x-ray (time frame: 6 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 25 Oct 2018.