Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimization of SPECT Imaging (OSCARS)

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.
ClinicalTrials.gov Identifier: NCT01519973
Recruitment Status : Terminated (Recruitment base changed due to change in clinical acquisition procedures)
First Posted : January 27, 2012
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE July 15, 2011
First Posted Date  ICMJE January 27, 2012
Last Update Posted Date April 24, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2013)
• 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
• 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.
Change History Complete list of historical versions of study NCT01519973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Determine the incremental benefit of AC/SC/RR compared to AC alone
  • Evaluate the effect on accuracy of using software with RR to reduce the acquisition time to half of the standard time.
  • Determine if using a registered diagnostic CT (PET) increases the accuracy of CT-based AC over the lower-quality Hawkeye CT (SPECT).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimization of SPECT Imaging
Official Title  ICMJE Optimization of SPECT Cardiac Imaging Through Compensation for Attenuation, Resolution Loss and Scatter - The OSCARS
Brief 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Radiation: SPECT/CT processed with Evolution for CardiacTM software
SPECT/CT to be compared with PET/CT
Study Arms  ICMJE 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.
Intervention: Radiation: SPECT/CT processed with Evolution for CardiacTM software
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 20, 2012)
64
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2012)
284
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01519973
Other Study ID Numbers  ICMJE HI Protocol #2008012-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This trial has concluded and the investigators have published from the available data.
Responsible Party Terrence Ruddy, Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terrence D Ruddy, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP