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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01993303
Enrollment
19
Registered
2013-11-25
Start date
2004-01-31
Completion date
2012-06-30
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Myocardial Perfusion Imaging, PET, Rb-82

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.

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.

Interventions

None listed

Sponsors

Cardiovascular Imaging Technologies
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantitative Accuracy1 dayTo establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.
Visual Assessment1 dayTo establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026