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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993303
• Other study ID #: CVIT-01-2012
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: November 20, 2013
• Start date: January 2004
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Cardiovascular Imaging Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Saint Lukes Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Imaging Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Accuracy	To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.	1 day	No
Primary	Visual Assessment	To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.	1 day	No