Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- CTP as predictive marker for efficacy measured by progression-free survival
研究概览
简要总结
The primary objective of this study is to investigate the anti-angiogenic effect of bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free survival (PFS) in mCRC patients under first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy
详细描述
So far, CTP has provided non-invasive imaging of tumor biological response to anti-angiogenic and vascular targeting agents in a number of clinical trials with increasing clinical application. CTP can be examined with a variety of commercially available CE-certified CT scanners and imaging post-processing is possible with commercially available CE-certified software from different vendors, too. In several studies, anti-angiogenic effects have been detected with CTP but further evidence for its clinical validation has to be proven in clinical trials.
Changes in tumor vasculature measured by CTP will be correlated to the clinical efficacy parameters progression-free survival, overall survival and response rate, thus identifying a group of patients who profit most from the anti-angiogenic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years, male or female
- •Signed written informed consent
- •Patients with histologically confirmed diagnosis of colorectal cancer with hepatic metastases who are candidates for systemic treatment.
- •Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures:
- •Contrast-enhanced spiral computed tomography showing at least one liver nodule ≥ 20 mm in longest diameter according to RECIST 1.1 criteria
- •MR imaging of the liver with liver lesions suspicious for metastases
- •PET computed tomography (PET/CT) with liver lesions suspicious for metastases
- •Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy.
- •ECOG performance status ≤ 2 (see appendix)
排除标准
- •Inability or unwillingness to comply with the participation requirements
- •History of untreated hyperthyreosis
- •History of intolerance of or allergy to iodine contrast media according to CTCAE V4.03
- •Calculated creatinine clearance < 45 ml/min
- •For fertile women: positive urine pregnancy test or lactation.
- •Known or suspected non-compliance, drug or alcohol abuse
- •Life expectancy of less than 3 months
- •Participation in another interventional trial with an investigational medicinal product (IMP) and within 30 days prior to screening
研究组 & 干预措施
Perfusion-computed tomography (CTP)
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
干预措施: Computed tomography X-ray system (Device)
结局指标
主要结局
CTP as predictive marker for efficacy measured by progression-free survival
时间窗: one year
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS). Decrease in tumor vasculature is measured by blood flow in CTP 3 compared to CTP 1 (baseline)
次要结局
- CTP as predictive marker for efficacy measured by progression-free survival(one year)
- Tumor vasculature at progression(one year)
- Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level(one year)
- Local and distant recurrences(one year)
- CTP as predictive marker for efficacy measured by overall survival(four years)
研究者
Patrick Veit-Haibach
PD MD
University of Zurich