Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00587730
Status:
TERMINATED
Last Update Posted:
2015-04-23
First Post:
2007-12-21
Brief Title:
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruiting or enrolling participants has halted prematurely and will not resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hawkeye
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None