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OpenTrials
Completed

NCT Number: NCT01993303

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Lukes Hospital

Kansas City, Missouri, 64111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cardiovascular Imaging Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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