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Direct Comparison of 2D Cardiac PET With 3D Cardiac PET

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ClinicalTrials.gov Identifier: NCT01993303
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Imaging Technologies

Brief Summary:
Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (~20 mCi) processed using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage (~50 mCi) 2D Rb-82 PET MPI.

Condition or disease
Coronary Artery Disease

Detailed Description:
This study re-examines 2D an 3D myocardial perfusion PET data from 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Rest and stress scans were acquired on a Siemens Accel™ PET scanner in 2D (septa extended) and 3D (septa retracted) modes. Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi. Imaging times were 2D emission scan for 3 mins (90 sec delay post Rb-82 infusion), followed by a 3 minute, 3D gated emission scan (180 sec delay). Decay and shorter acquisition times led to a 62% reduction in the effective dosage 2D vs 3D datasets. 3D images were first pre-processed using a Monte-Carlo scatter and prompt gamma correction algorithm (Imagen3D™) then reconstructed using ImagenProTM (CVIT, Kansas City, MO). Reconstructed images were evaluated using relative, 17 segment raw scores (Cedars QPET). Studies were read by consensus of 2-blinded readers for: image quality (1-4, poor-excellent), interpretive certainty (1-3, low-high) and rest perfusion using a 17 segment model (0=normal; 1-3 = mild, moderate, or severe perfusion defects). Stress segmental scores were not evaluated due to differences in imaging start time post dipyridamole infusion.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Direct Comparison of 2D Cardiac PET With 3D Cardiac PET Using a 3D Monte-Carlo Scatter COrrection Algorithm
Study Start Date : January 2004
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Group/Cohort
Single Cohort
Population: 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Radionuclide Dosage: Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi All were stress with Dipyridamole.



Primary Outcome Measures :
  1. Quantitative Accuracy [ Time Frame: 1 day ]
    To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.

  2. Visual Assessment [ Time Frame: 1 day ]
    To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male.
Criteria

Inclusion Criteria:

  • >18 Years of Age
  • Have ability to provide informed consent
  • Have a technically adequate rest/stress Rb-82 perfsion PET study within the past 60 days

Exclusion Criteria:

  • Pregnant or nursing feamle
  • Weight > 275 lbs
  • Have contraindications to adenosine stress testing
  • Unstable cardiac rhythm (atrial fibrillation, frequent PVCs
  • PTCA or CABG within the last 60 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993303


Locations
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United States, Missouri
Saint Lukes Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Cardiovascular Imaging Technologies
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Responsible Party: Cardiovascular Imaging Technologies
ClinicalTrials.gov Identifier: NCT01993303    
Other Study ID Numbers: CVIT-01-2012
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Cardiovascular Imaging Technologies:
Myocardial Perfusion Imaging
PET
Rb-82
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases