NCT01394926终止2 期
A Multi-Center, Open-Label, Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
研究概览
简要总结
The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is is greater than or equal to 18 years of age.
- •The subjects has highly suspected or established carotid artery disease.
- •The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure).
- •The subject has non-diagnostic U/S of the carotids as defined by institutional standards.
排除标准
- •The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
- •The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
- •The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
- •The subject has right to left, bi-directional or transient right to left cardiac shunts.
研究组 & 干预措施
Arm Number 1
Experimental
干预措施: Optison (Drug)
结局指标
主要结局
Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
时间窗: Up to 10 minutes post contrast administration.
Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.
次要结局
- Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.(Up to 10 minutes post contrast administration.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast CancerLocally Recurrent and Metastatic Breast CancerNCT00322400Amgen46
已完成
2 期
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe NeutropeniaNeutropeniaBreast CancerNCT00497809AviGenics189
已完成
1 期
A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed MyelomaMultiple MyelomaNCT01660750Criterium, Inc.29
已完成
1 期
Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Solid TumorsSolid TumorsNCT04261413RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.16
已完成
1 期
A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid TumorsAdvanced and Selected Solid TumorsHigh Risk and Very High Risk MDSAMLNCT01449058Array BioPharma139