跳至主要内容
临床试验/NCT05669287
NCT05669287招募中不适用

Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
主要终点
Correlation of CT-perfusion features with histopathological features

研究概览

简要总结

With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome.

The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.

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
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

入选标准

  • Clinical suspicion of pancreatic cancer
  • 18 years and older
  • written (signed and dated) informed consent

排除标准

  • Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
  • Previous treatment for pancreatic cancer
  • Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
  • Insufficient command of the Dutch language to be able to understand the patient information

结局指标

主要结局

Correlation of CT-perfusion features with histopathological features

时间窗: Baseline, Time of Resection

To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma

Classification of vascular phenotype using CT-perfusion

时间窗: Baseline

To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma

次要结局

  • Association between survival and CT-perfusion features(Baseline, at 2 Years)
  • Prediction of chemotherapy response(Baseline, 3 Months)
  • Prediction of chemotherapy response compared to RECIST(Baseline, 3 Months, 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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