Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Phase 2

Terminated

• Conditions: Cardiac Disease
• Interventions: Device: GE Attenuation Corrected Hawkeye Camera

• Registration Number: NCT00587730
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 608

Inclusion Criteria

• Patients referred to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT

Exclusion criteria:

• Prior PTCA or CABG
• Left bundle branch block (LBBB) or paced ventricular rhythm
• Clinically significant valvular heart disease
• Hypertrophic or idiopathic dilated cardiomyopathy
• Atrial fibrillation or frequent atrial or ventricular ectopy (defined as >20% ectopic beats
• History of MI
• ECG evidence of MI
• Chest circumference >55 inches

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical SPECT	GE Attenuation Corrected Hawkeye Camera	GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.

Primary Outcome Measures

Name	Time	Method
The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test.	Measured/Compared at time of each scan.

Secondary Outcome Measures

Name	Time	Method
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.	Measured/Compared at time of study

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States