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

Direct Comparison of 2D Cardiac PET With 3D Cardiac PET Using a 3D Monte-Carlo Scatter COrrection Algorithm

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Lukes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Accuracy	To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.	1 day
Visual Assessment	To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.	1 day

Collaborators and Investigators

• Sponsor: Cardiovascular Imaging Technologies

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: PET; Myocardial Perfusion Imaging; Rb-82
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CVIT-01-2012