NCT01674556已完成1 期
Treatment of Pancreatic Adenocarcinoma by Combining Contrast Agent and Gemitabine Under Sonification
Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
研究概览
简要总结
The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours
The specific sub-objectives of the studies are:
- To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method.
- To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
- Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy.
- To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
- To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.
详细描述
The primary outcome is monitor for toxicity effect for the combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate
排除标准
- •Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
- •Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
- •Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
- •Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
- •Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
- •Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
- •Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
- •Patient is pregnant or is breast-feeding.
- •Patient is allergic to or intolerant of gemcitabine
- •Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究组 & 干预措施
Contrast-enhanced ultrasound (CEUS)
Experimental
干预措施: Gemzar (Drug)
结局指标
主要结局
Toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
时间窗: Two years
To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
次要结局
- tumor size(one year)
研究者
研究点 (1)
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