Pulmonary Nodule, SolitaryNCT00963651
GE Healthcare VolumeRAD Lung Nodule Detection Study
An observational study of Pulmonary Nodule, Solitary and Multiple Pulmonary Nodules, run by American College of Radiology - Image Metrix at 4 sites in 2 countries.
Trial summary
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Nodule, Solitary, Multiple Pulmonary Nodules
- What is being tested?
- Chest tomosynthesis and X-ray
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2009to Jul 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.
Who may be able to join
- Scheduled for chest CT as part of their needed medical care;
- If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
- 18 years of age, or older;
- In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.
Who cannot join
- Children under 18 years of age;
- Women who are pregnant or who suspect they may be pregnant;
- Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
- Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
- Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
- Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48103
Duke University Medical Center
Durham, North Carolina, 27705
University of Washington Medical Center
Seattle, Washington, 98195
About this study
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
Read the detailed description
Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography.
The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.
- Being tested
- Chest tomosynthesis and X-ray
- Keywords
- Pulmonary nodule, solitary, Multiple pulmonary nodules
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tomosynthesis and X-rayDevice
VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of pulmonary nodules | Eligible participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons. Receives: Device: Chest tomosynthesis and X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
The primary objective of this study is to determine if the use of VolumeRAD tomosynthesis increases the accuracy of the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional PA and lateral chest radiography alone.
Measured: Post accrual of 210 participants
Secondary outcomes (1)
Actionability classification accuracy of all modalities
Measured: Multipe reader, multiple case reader study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology - Image Metrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- James Dobbins, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963651
- Sponsor's protocol ID
- GE-VORTEX
- Other IDs
- GE 2901
- Status last verified
- Jul 2013
- First submitted
- 20 Aug 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GE Healthcare VolumeRAD Lung Nodule Detection Study
- ClinicalTrials.gov ID
- NCT00963651
- Acronym / sponsor ID
- GE-VORTEX
- Keywords
- Pulmonary nodule, solitary, Multiple pulmonary nodules
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- American College of Radiology - Image MetrixIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- Aug 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Aug 2009 (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.
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
Detailed description
Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography.
The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of pulmonary nodules | – | Device: Chest tomosynthesis and X-rayEligible participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.
Key inclusion criteria (4 listed)
- Scheduled for chest CT as part of their needed medical care;
- If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
- 18 years of age, or older;
- In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.
Key exclusion criteria (6 listed)
- Children under 18 years of age;
- Women who are pregnant or who suspect they may be pregnant;
- Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
- Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
- Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
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 |
|---|---|---|
| Chest tomosynthesis and X-rayVolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images) | Device | Suspicion of pulmonary nodules |
Primary outcome
Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
Time frame: Post accrual of 210 participants
The primary objective of this study is to determine if the use of VolumeRAD tomosynthesis increases the accuracy of the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional PA and lateral chest radiography alone.
1 secondary outcome
Actionability classification accuracy of all modalities
Time frame: Multipe reader, multiple case reader study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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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.
James Dobbins, MD principal investigator
Duke University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Multiple Pulmonary Nodules, run by American College of Radiology - Image Metrix at 4 sites in 2 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology. (time frame: Post accrual of 210 participants). 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 24 Jul 2013.