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NCT00587730 · ClinicalTrials.gov registry record · Phase 2
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 608
- Enrollment target
NCT00587730: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT00587730 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 608 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587730, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 608 participants
- Enrollment target
Study 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).
Interventions
- DEVICE GE Attenuation Corrected Hawkeye Camera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2001-07 |
| Est. Completion | 2004-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00587730
The ClinicalTrials.gov registry entry for NCT00587730 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GE Attenuation Corrected Hawkeye Camera is the first listed.
NCT00587730 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00587730 about?
NCT00587730 is a clinical study titled "Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System". 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 ca...
What is the current status of trial NCT00587730?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 608 participants. The study started on 2001-07. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00587730?
The interventions under investigation include: GE Attenuation Corrected Hawkeye Camera (DEVICE).
Who is sponsoring clinical trial NCT00587730?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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