Optimization of SPECT Imaging (OSCARS)

April 21, 2017 updated by: Terrence Ruddy, Ottawa Heart Institute Research Corporation

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
SPECT/CT to be compared with PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the incremental benefit of AC/SC/RR compared to AC alone
Time Frame: 2 years
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
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
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This trial has concluded and the investigators have published from the available data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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