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Optimization of SPECT Imaging (OSCARS)

This study has been terminated.
(Recruitment base changed due to change in clinical acquisition procedures)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519973
First Posted: January 27, 2012
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation
  Purpose
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.

Condition Intervention
Coronary Artery Disease Radiation: SPECT/CT processed with Evolution for CardiacTM software

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimization of SPECT Cardiac Imaging Through Compensation for Attenuation, Resolution Loss and Scatter - The OSCARS

Resource links provided by NLM:


Further study details as provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Evaluation of technology in SPECT
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.
Radiation: SPECT/CT processed with Evolution for CardiacTM software
SPECT/CT to be compared with PET/CT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intermediate to high risk patients with coronary artery disease who are scheduled for routine SPECT or PET perfusion imaging

Exclusion Criteria:

  • Pregnancy and breast feeding
  • Severe narrowing (stenosis) of the aortic valve
  • Severe heart failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519973


Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Terrence D Ruddy, MD Ottawa Heart Institute Research Corporation
  More Information

Publications:
Responsible Party: Terrence Ruddy, Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01519973     History of Changes
Other Study ID Numbers: HI Protocol #2008012-01H
First Submitted: July 15, 2011
First Posted: January 27, 2012
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This trial has concluded and the investigators have published from the available data.

Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
Diagnostic imaging
Single Photon Emission Computed Tomography
Positron emission tomography
Computed tomography
Attenuation
Resolution
Scatter
Radiopharmaceutical

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases