123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
研究概览
简要总结
The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New York Heart Association Class II or III Heart Failure
- •Left ventricular ejection fraction less than or equal to 35%
排除标准
- •Uncompensated heart failure
- •Recent hospitalization within 30 days of cardiac related indications
研究组 & 干预措施
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging
SPECT imaging of 10 millicurie of Adreview
干预措施: AdreView (Drug)
Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging
SPECT imaging of 10 millicurie of Adreview
干预措施: Single Photon Emission Computed Tomography (Other)
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging
SPECT imaging of 10 millicurie of Adreview
干预措施: AdreView (Drug)
AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging
SPECT imaging of 10 millicurie of Adreview
干预措施: Single Photon Emission Computed Tomography (Other)
结局指标
主要结局
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
时间窗: 3 months post-enrollment close
H/M ratios as described will be calculated for the LFOV, and SFOV-HE data sets to determine the correlation between the two measurements. The r value, slope and intercept of this correlation will constitute the primary endpoint of this study. Specifically, we will establish the r value, slope and intercept for: LFOV-Planar vs LFOV-TOMO, LFOV-Planar vs SFOV-HE-TOMO, LFOV-TOMO vs SFOV-HE-TOMO.
次要结局
- Image Quality(3 month post-enrollment close)
研究者
Timothy M. Bateman
Medical Director
Aspire Foundation