Coronary Artery DiseaseOSCARSNCT01519973
Optimization of SPECT Imaging
A study testing SPECT/CT processed with Evolution for CardiacTM software in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. There are three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SPECT/CT processed with Evolution for CardiacTM software
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Aug 2012
- 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
- Intermediate to high risk patients with coronary artery disease who are scheduled for routine SPECT or PET perfusion imaging
Who cannot join
- Pregnancy and breast feeding
- Severe narrowing (stenosis) of the aortic valve
- Severe heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of SPECT Cardiac Imaging Through Compensation for Attenuation, Resolution Loss and Scatter - The OSCARS
Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. There are three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where the signal gets blurrier the further the nuclear activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and new cameras with computed tomography (CT) decrease the time needed for images to be obtained while maintaining image quality. Evaluation is needed before they become standard of care.
- Conditions
- Coronary Artery Disease
- Being tested
- SPECT/CT processed with Evolution for CardiacTM software
- Keywords
- Diagnostic imaging, Single Photon Emission Computed Tomography, Positron emission tomography, Computed tomography, Attenuation, Resolution, Scatter, Radiopharmaceutical
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CT processed with Evolution for CardiacTM softwareRadiation
SPECT/CT to be compared with PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of technology in SPECT | Other | Evaluation of the accuracy of SPECT with new technologies for attenuation correction (AC), scatter correction (SC) and resolution recovery (RR) for assessment of myocardial perfusion using Rb-82 PET as the gold standard. Receives: Radiation: SPECT/CT processed with Evolution for CardiacTM software |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Determine the accuracy of myocardial perfusion assessment using SPECT with AC/SC/RR compared to Rb-82 PET.
We are proposing a study to evaluate the accuracy of SPECT with the new technologies for attenuation correction (AC), scatter compensation (SC) and resolution recovery (RR) for the assessment of myocardial perfusion in patients with heart disease using Rb-82 perfusion PET as the gold standard for comparison.
Measured: 2 years
Secondary outcomes (4)
Determine the incremental benefit of AC/SC/RR compared to AC alone
Measured: 2 years
Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time.
Measured: 2 years
Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT).
Measured: 2 years
Determine if using a single CT scan acquired at stress for attenuation correction of both stress and rest SPECT decreases the accuracy over using CT scans acquired separately at rest and stress.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Recruitment base changed due to change in clinical acquisition procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence D Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519973
- Sponsor's protocol ID
- HI Protocol #2008012-01H
- Acronym
- OSCARS
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This trial has concluded and the investigators have published from the available data.
Publications
Wells RG, Soueidan K, Vanderwerf K, Ruddy TD. Comparing slow- versus high-speed CT for attenuation correction of cardiac SPECT perfusion studies. J Nucl Cardiol. 2012 Aug;19(4):719-26. doi: 10.1007/s12350-012-9555-4. Epub 2012 Apr 21.
PubMed 22527797Wells RG, Soueidan K, Timmins R, Ruddy TD. Comparison of attenuation, dual-energy-window, and model-based scatter correction of low-count SPECT to 82Rb PET/CT quantified myocardial perfusion scores. J Nucl Cardiol. 2013 Oct;20(5):785-96. doi: 10.1007/s12350-013-9738-7. Epub 2013 Jun 5.
PubMed 23737161
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of SPECT Cardiac Imaging Through Compensation for Attenuation, Resolution Loss and Scatter - The OSCARS
- ClinicalTrials.gov ID
- NCT01519973
- Acronym / sponsor ID
- OSCARS / HI Protocol #2008012-01H
- Conditions
- Coronary Artery Disease
- Keywords
- Diagnostic imaging, Single Photon Emission Computed Tomography, Positron emission tomography, Computed tomography, Attenuation, Resolution, Scatter, Radiopharmaceutical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment base changed due to change in clinical acquisition procedures
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jan 2012 (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.
Single Photon Emission Computed Tomography (SPECT) is a 3D nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. There are three major limitations in SPECT imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where the signal gets blurrier the further the nuclear activity is away from the camera. New software, Evolution for CardiacTM, by GE Healthcare and new cameras with computed tomography (CT) decrease the time needed for images to be obtained while maintaining image quality. Evaluation is needed before they become standard of care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of technology in SPECT | Other | Radiation: SPECT/CT processed with Evolution for CardiacTM softwareEvaluation of the accuracy of SPECT with new technologies for attenuation correction (AC), scatter correction (SC) and resolution recovery (RR) for assessment of myocardial perfusion using Rb-82 PET as the gold standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intermediate to high risk patients with coronary artery disease who are scheduled for routine SPECT or PET perfusion imaging
Key exclusion criteria (3 listed)
- Pregnancy and breast feeding
- Severe narrowing (stenosis) of the aortic valve
- Severe heart failure
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 |
|---|---|---|
| SPECT/CT processed with Evolution for CardiacTM softwareSPECT/CT to be compared with PET/CT | Radiation | Evaluation of technology in SPECT |
Primary outcome
• Determine the accuracy of myocardial perfusion assessment using SPECT with AC/SC/RR compared to Rb-82 PET.
Time frame: 2 years
We are proposing a study to evaluate the accuracy of SPECT with the new technologies for attenuation correction (AC), scatter compensation (SC) and resolution recovery (RR) for the assessment of myocardial perfusion in patients with heart disease using Rb-82 perfusion PET as the gold standard for comparison.
4 secondary outcomes
Determine the incremental benefit of AC/SC/RR compared to AC alone
Time frame: 2 years
Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time.
Time frame: 2 years
Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT).
Time frame: 2 years
Determine if using a single CT scan acquired at stress for attenuation correction of both stress and rest SPECT decreases the accuracy over using CT scans acquired separately at rest and stress.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment base changed due to change in clinical acquisition procedures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Results publication: PubMed 22527797Wells RG, Soueidan K, Vanderwerf K, Ruddy TD. Comparing slow- versus high-speed CT for attenuation correction of cardiac SPECT perfusion studies. J Nucl Cardiol. 2012 Aug;19(4):719-26. doi: 10.1007/s12350-012-9555-4. Epub 2012 Apr 21.
- Results publication: PubMed 23737161Wells RG, Soueidan K, Timmins R, Ruddy TD. Comparison of attenuation, dual-energy-window, and model-based scatter correction of low-count SPECT to 82Rb PET/CT quantified myocardial perfusion scores. J Nucl Cardiol. 2013 Oct;20(5):785-96. doi: 10.1007/s12350-013-9738-7. Epub 2013 Jun 5.
- Individual participant dataSharing planned: No. This trial has concluded and the investigators have published from the available data.
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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.
Terrence D Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT/CT processed with Evolution for CardiacTM software in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation 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 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: stopped early, as of the sponsor's last update on 24 Apr 2017. 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: Recruitment base changed due to change in clinical acquisition procedures). 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?
• Determine the accuracy of myocardial perfusion assessment using SPECT with AC/SC/RR compared to Rb-82 PET. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01519973, which also lists 2 linked publications.
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 Apr 2017.