Reducing Radioisotope Dose: the Half-Dose CZT Study
2019年9月4日 更新者：S.M.Chang, MD
Reducing Radioisotope Dose in Regadenoson SPECT Myocardial Perfusion Imaging: Comparison of Half-Dose Scans Using a Novel Solid-State-Detector Dedicated Cardiac Camera to Full Dose Scans Acquired On Standard Equipment
This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.
研究概览
详细说明
The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera.
The proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system.
研究类型
介入性
注册 (实际的)
74
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Texas
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Houston、Texas、美国、77030
- Houston Methodist Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study
- suspected or known coronary artery disease
- written informed consent
Exclusion Criteria:
- Evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal
- Participation in another investigational study within the preceding month
- Pregnant and/or breast-feeding female
- ECG evidence of left bundle branch block or paced rhythm
- Evidence of non-ischemic cardiomyopathy
- Presence of hypertrophic cardiomyopathy and/or severe valvular heart disease
- Severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure)
- Known allergy to technetium-99m
- Potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate < 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Half-dose isotope for NuclearStressTest
Intervention is Nuclear stress test of the heart.
Single-arm of this study "Half-dose of isotope for Nuclear stress test" is group of study subjects who will do Research Nuclear stress test with half-dose of isotope that normally used for routine Nuclear stress test.
Isotope is the tracer CZT (cadmium zinc telluride) that used for Nuclear stress test routinely to see the function of arteries of the heart.
Patients with suspected Coronary Artery Disease who meet entry criteria undergo a research nuclear stress test using a decreased dose of isotope, using a new camera.
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Half-dose of tracer or radioisotope will be used for Nuclear stress test of the heart.
This is imaging test of the heart to see the function of arteries of the heart.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Image quality of the half-dose CZT versus full dose scans
大体时间：1 Week
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1 Week
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Total radiation dose/exposure of the half-dose CZT vs. full dose scans
大体时间：1 Week
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1 Week
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Total myocardial count activity and count rates obtained during each scan
大体时间：1 Week
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1 Week
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Agreement between the half-dose CZT vs. full dose scans on the presence and extent of fixed or reversible defects on a per-patient and vessel basis
大体时间：1 Week
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1 Week
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Agreement between the half-dose vs. full dose scans on gated data such as EF, left ventricular (LV) end-diastolic volume, LV end-systolic volume
大体时间：1 Week
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1 Week
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Su Min Chang, MD、The Methodist Hospital Research Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90. doi: 10.1016/j.nuclcard.2006.08.011. No abstract available.
- Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.
- Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249.
- Radiation dose to patients from radiopharmaceuticals (addendum 2 to ICRP publication 53). Ann ICRP. 1998;28(3):1-126. doi: 10.1016/s0146-6453(99)00006-8.
- Einstein AJ, Henzlova MJ, Rajagopalan S. Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography. JAMA. 2007 Jul 18;298(3):317-23. doi: 10.1001/jama.298.3.317.
- The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.
- Shaw LJ, Iskandrian AE. Prognostic value of gated myocardial perfusion SPECT. J Nucl Cardiol. 2004 Mar-Apr;11(2):171-85. doi: 10.1016/j.nuclcard.2003.12.004. No abstract available.
- Fazel R, Shaw LJ. Radiation exposure from radionuclide myocardial perfusion imaging: concerns and solutions. J Nucl Cardiol. 2011 Aug;18(4):562-5. doi: 10.1007/s12350-011-9403-y. No abstract available.
- Herzog BA, Buechel RR, Katz R, Brueckner M, Husmann L, Burger IA, Pazhenkottil AP, Valenta I, Gaemperli O, Treyer V, Kaufmann PA. Nuclear myocardial perfusion imaging with a cadmium-zinc-telluride detector technique: optimized protocol for scan time reduction. J Nucl Med. 2010 Jan;51(1):46-51. doi: 10.2967/jnumed.109.065532. Epub 2009 Dec 15.
- Buechel RR, Herzog BA, Husmann L, Burger IA, Pazhenkottil AP, Treyer V, Valenta I, von Schulthess P, Nkoulou R, Wyss CA, Kaufmann PA. Ultrafast nuclear myocardial perfusion imaging on a new gamma camera with semiconductor detector technique: first clinical validation. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):773-8. doi: 10.1007/s00259-009-1375-7. Epub 2010 Jan 27. Erratum In: Eur J Nucl Med Mol Imaging. 2011 Jun;38(6):1172.
- Esteves FP, Raggi P, Folks RD, Keidar Z, Askew JW, Rispler S, O'Connor MK, Verdes L, Garcia EV. Novel solid-state-detector dedicated cardiac camera for fast myocardial perfusion imaging: multicenter comparison with standard dual detector cameras. J Nucl Cardiol. 2009 Nov-Dec;16(6):927-34. doi: 10.1007/s12350-009-9137-2. Epub 2009 Aug 18.
- Gimelli A, Bottai M, Giorgetti A, Genovesi D, Kusch A, Ripoli A, Marzullo P. Comparison between ultrafast and standard single-photon emission CT in patients with coronary artery disease: a pilot study. Circ Cardiovasc Imaging. 2011 Jan;4(1):51-8. doi: 10.1161/CIRCIMAGING.110.957399. Epub 2010 Nov 10.
- Duvall WL, Croft LB, Ginsberg ES, Einstein AJ, Guma KA, George T, Henzlova MJ. Reduced isotope dose and imaging time with a high-efficiency CZT SPECT camera. J Nucl Cardiol. 2011 Oct;18(5):847-57. doi: 10.1007/s12350-011-9379-7. Epub 2011 Apr 29.
- Duvall WL, Sweeny JM, Croft LB, Barghash MH, Kulkarni NK, Guma KA, Henzlova MJ. Comparison of high efficiency CZT SPECT MPI to coronary angiography. J Nucl Cardiol. 2011 Aug;18(4):595-604. doi: 10.1007/s12350-011-9382-z. Epub 2011 Jun 3.
- Mahmarian JJ, Shaw LJ, Olszewski GH, Pounds BK, Frias ME, Pratt CM; INSPIRE Investigators. Adenosine sestamibi SPECT post-infarction evaluation (INSPIRE) trial: A randomized, prospective multicenter trial evaluating the role of adenosine Tc-99m sestamibi SPECT for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction. J Nucl Cardiol. 2004 Jul-Aug;11(4):458-69. doi: 10.1016/j.nuclcard.2004.05.003.
- ICRP. Radiation dose to patients from radiopharmaceuticals. Addendum 3 to ICRP Publication 53. ICRP Publication 106. Approved by the Commission in October 2007. Ann ICRP. 2008;38(1-2):1-197. doi: 10.1016/j.icrp.2008.08.003.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2016年12月16日
研究完成 (实际的)
2016年12月16日
研究注册日期
首次提交
2012年1月23日
首先提交符合 QC 标准的
2012年1月25日
首次发布 (估计)
2012年1月26日
研究记录更新
最后更新发布 (实际的)
2019年9月6日
上次提交的符合 QC 标准的更新
2019年9月4日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.