Optimization of SPECT Imaging (OSCARS)

This study has been terminated.
(Recruitment base changed due to change in clinical acquisition procedures)
Sponsor:
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01519973
First received: July 15, 2011
Last updated: October 8, 2014
Last verified: October 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 15, 2011
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by 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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014