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临床试验/NCT01993303
NCT01993303已完成不适用

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

Cardiovascular Imaging Technologies1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Quantitative Accuracy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >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

排除标准

  • 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

结局指标

主要结局

Quantitative Accuracy

时间窗: 1 day

To establish the quantitative accuracy of reconstructed volumes using Imagen3DTM when compared to other methods.

Visual Assessment

时间窗: 1 day

To establish that visual assessments of image quality and reader confidence using 3D data are equivalent to the other methods.

次要结局

未报告次要终点

研究者

发起方
Cardiovascular Imaging Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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