A Phase 2/3 interventional study of GE Attenuation Corrected Hawkeye Camera in Cardiac Disease, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-23.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Diagnostic
The accuracy of stress single photon emission computed tomography (SPECT) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress SPECT. These patients will undergo SPECT imaging both with conventional methodology and the GE Hawkeye system. The conventional study will be interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. The primary study hypothesis is that AC will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (MI). Clinical data and noninvasive test results (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to MI (true-positive).
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 608 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion criteria:
GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.
Device: GE Attenuation Corrected Hawkeye Camera
GE Hawkeye AC system and 360˚ camera orbit
The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test.
Time frame: Measured/Compared at time of each scan.
Comparisons of categorical factors between the 2 tests will also be completed using McNemar's test, continuous factors will be completed using a paired t-test if the differences are normally distributed.
Time frame: Measured/Compared at time of study
This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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