Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- difference in measured response between treated and untreated lesions
研究概览
简要总结
The aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver metastases from breast cancer and colorectal cancer will be included. Computer Tomography (CT) will be performed as a baseline scan before treatment start. Two metastases in each patients liver will be preselected and randomized to either "target lesion" to be treated or "control lesion" to serve as internal control. The patients will receive conventional treatment with chemotherapy according to national guidelines. After intravenous chemotherapy infusion the patients will receive the experimental treatment. The target lesion will get focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be administered intravenously. The investigators will measure the difference in response between FUS- treated and -untreated lesions on the post-treatment CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Histologically verified breast carcinoma or colorectal carcinoma
- •2 or multiple liver metastases
- •considered eligible by a consulting oncologist for first line treatment with chemotherapy in the group of taxanes (patients with breast cancer) or the combination regimen FOLFIRI (patients with colorectal carcinoma)
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
排除标准
- •Known contraindications for ultrasound contrast-enhancement agent Sonovue® (Bracco)
- •Hematological bleeding status before experimental treatment: Hb < 8g/dL, trc < 80 x109/l, APTT˃ 45s, INR ˃ 1,5
- •Considered eligible for surgical removal of liver metastases
- •Pregnancy
研究组 & 干预措施
Breast cancer target lesion
This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for breast cancer.
干预措施: SonoVue (Drug)
Breast cancer target lesion
This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for breast cancer.
干预措施: Focused Ultrasound (Procedure)
Breast cancer control lesion
This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.
干预措施: SonoVue (Drug)
Colorectal cancer target lesion
This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for colorectal cancer.
干预措施: SonoVue (Drug)
Colorectal cancer target lesion
This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for colorectal cancer.
干预措施: Focused Ultrasound (Procedure)
Colorectal cancer control lesion
This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.
干预措施: SonoVue (Drug)
结局指标
主要结局
difference in measured response between treated and untreated lesions
时间窗: From baseline examination CT to response evaluation CT: 10-12 weeks
Response is measured in change in size of the treated metastases.
次要结局
- Occurrence of adverse effects(8 weeks)