Prediction and Evaluation of Chemotherapy Treatment Response Using Contrast Enhanced Ultrasound in Unresected Localized Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RECIST 1.1 Therapeutic Responses to 4 cycles
研究概览
简要总结
The goal of this observational study is to explore whether contrast-enhanced ultrasound (CEUS) can early predict and evaluate the treatment response of first-line chemotherapy in locally advanced and borderline resectable pancreatic cancers.
The main questions it aims to answer are:
Question 1: What quantitative parameters of CEUS performed before first-line chemotherapy can predict the early treatment response of patients with locally pancreatic cancer?Question 2: Can CEUS reflect early neovascular changes after first-line chemotherapy in pancreatic tumors? Participants will receive CEUS examination carried out by experienced operators before the first cycle of chemotherapy and after 2 treatment cycles.
详细描述
Pancreatic cancer is a highly fatal disease with a low 5-year survival rate of approximately 9% in the United States. Due to vague symptoms and early involvement of vessels, surgical treatment is only feasible for 20% of patients. First-line chemotherapy, which can improve the rate of R0 resection, is increasingly being used and is preferred in the ASCO guidelines for patients with locally advanced and borderline resectable pancreatic cancers. Early prediction and evaluation of the treatment response can provide prognostic information and enable oncologists to tailor therapeutic strategies.
Contrast-enhanced ultrasound (CEUS) is of interest for its ability to gain macrovascular and microvascular information about organs and to aid our understanding of the complexity of angiogenesis in different types of tumors. CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in pancreatic tumors even at the capillary level. Our previous studies have confirmed that the enhancement patterns of CEUS in pancreatic ductal adenocarcinoma (PDAC) have correlation with the overall survival time. Now we hypothesize that the enhancement patterns before first-line chemotherapy can predict the treatment response and the changes in the pharmacokinetics of contrast material after treatment would reflect early neovascular changes in pancreatic tumors.
The investigators plan to recruit patients who are about to receive first-line chemotherapy for pathologically diagnosed PDAC from the department of General Surgery and Medical Oncology of our hospital. The patients will receive CEUS examination before the first cycle of chemotherapy and after 2 treatment cycles. Quantitative perfusion analysis will be performed by experienced radiologists and artificial intelligence for all of the images. According to the published literature, clinical response in patients were evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) combined with the changes of serum levels of CA 19-9. Changes of CEUS quantitative perfusion parameters will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, serum CA 19-9 levels and repeat pathology as applicable
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 main inclusion criteria were histologically proven pancreatic ductal adenocarcinoma and medical fitness for first-line chemotherapy Patients were consent to receive examinations of contrast enhanced ultrasound
排除标准
- •Patients with distal metastases or patients refusing chemotherapy Patients who were not suitable for contrast-enhanced ultrasound ,such as pregnant or lactating women Patients without complete clinical data
结局指标
主要结局
RECIST 1.1 Therapeutic Responses to 4 cycles
时间窗: estimated to be 4 months
The patients underwent baseline and repeat MDCT imaging (after 4 cycle). Tumor response was determined by RECIST 1.1 and was defined as a \>30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion.
Serum CA 19-9 Responses to 4 cycles
时间窗: estimated to be 4 months
Serum CA19-9 levels were detected before chemotherapy and at the end of Cycle 4(each cycle is 21 days). Patients with normal CA19-9(\<37 U/mL) post-chemotherapy, whether normal or elevated pre-chemotherapy are defined as "Optimal CA19-9 Response".
Evaluate if tumor uptake of contrast agent is predictive of response to chemotherapy therapy measured by comparison of Peak Intensity (PI) at CEUS imaging prior to and after 2 cycles chemotherapy
时间窗: Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)
Before initiation of the chemotherapy and at the end of Cycle 2 (each cycle is 21 days) of chemotherapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time-intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA) and artificial intelligence. PI measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, serum CA 19-9 levels and repeat pathology as applicable.
Evaluate if the time to peak (TP) is predictive of response to chemotherapy therapy measured by comparison of TP at CEUS imaging prior to the start of first-line chemotherapy and TP at imaging performed after 2 cycles chemotherapy
时间窗: Baseline and after 2 cycles of chemotherapy (estimated to be 2 months)
Before initiation of the chemotherapy and at the end of Cycle 2 (each cycle is 21 days) of chemotherapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time-intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA) and artificial intelligence. TP measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, serum CA 19-9 levels and repeat pathology as applicable.
次要结局
- Assessment of overall survival(From first day of protocol examination to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive up to 2 years)