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临床试验/NCT06144762
NCT06144762招募中不适用

Precision Imaging for Early Detection and Targeted Treatment Monitoring in Pancreatic Cancer

Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
the integration of in vivo and ex vivo MRI with histology and molecular caracteristic in order to increase the pancreatic cancer detection and therapeutic response monitoring

研究概览

简要总结

Specifically, in this project, the objective will be developped a model to capture imaging-based tumor heterogeneity with multiscale radiomics approach by obtaining the mirror tumor image at in vivo MRI, ex vivo MRI at histology. This imaging model giving a perfect virtual histology tumor representation will be secondary implemented on routine in vivo clinical MRI for early cancer detection and treatment monitoring. Successful completion of this proposal will lead to a comprehensive non invasive characterisation of pancreatic cancer and will be a game changer in patient management.

详细描述

With a five-year survival rate of only 3% for the majority of patients, pancreatic cancer is a global healthcare challenge. By the time of diagnosis over half of pancreatic cancers are metastasized. The dire disease situation reflects our inability to diagnose pancreatic cancer early and to effectively treat it. Our failure to diagnose the disease early results in part from the inaccessibility of the organ, difficulties in detecting small pancreatic lesions by conventional imaging approaches, and a poor understanding of the spectrum of heterogeneity in pancreatic cancer. Single time point, single site biopsies cannot assess entire tumor while multiple biopsies at several time points are not feasible in clinical routine. Limitations of invasive sampling may be addressed with non-invasive imaging that captures morphologic and functional information about the entire tumor in space and, if repeated, in time. Radiomics has the potential for "whole tumour virtual sampling" using a single or serial non-invasive examinations in place of biopsies. By approaching images as data able to be mined, instead of merely pictures in conventional radiology, quantitative imaging allows for further information to be extracted from medical images as well as for global assessments across large patient populations. Therefore, these new quantitative approaches hold the promise of detecting pancreatic cancer characteristics that the naked eye alone cannot perceive from conventional medical imaging, opening new doors for personalized medicine in pancreatic cancer. To date, no study has evaluated the value of radiomics at macroscopic (in vivo 1.5T/3TMRI) and microscopic (ex vivo 9.4TMRI) scale for early cancer detection and targeted treatment monitoring. Specifically, in this project, the objective will be developpe a model to capture imaging-based tumor heterogeneity with multiscale radiomics approach by obtaining the mirror tumor image at in vivo MRI, ex vivo MRI at histology. This imaging model giving a perfect virtual histology tumor representation will be secondary implemented on routine in vivo clinical MRI for early cancer detection and treatment monitoring. Successful completion of this proposal will lead to a comprehensive non invasive characterisation of pancreatic cancer and will be a game changer in patient management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Patient aged >18
  • Pathologically proven pancreatic cancer which can beneficiate of upfront surgery or delayed surgery followed by neoadjuvant chemotherapy.
  • Negative pregnancy test for women of childbearing potential
  • Patients affiliated to a social protection system
  • Written informed consent signed before project onset.

排除标准

  • presence of metastases,
  • Patient who will not have surgery
  • Pregnant or breastfeeding women
  • Mental or psychological state, physical or legal incapacity preventing participation in the project.

结局指标

主要结局

the integration of in vivo and ex vivo MRI with histology and molecular caracteristic in order to increase the pancreatic cancer detection and therapeutic response monitoring

时间窗: The day of the surgery

The diagnostic performance of the radiomic and multiomic algorithm in pancreatic cancer detection and therapeutic response monitoring.

次要结局

  • the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale(The day of the surgery)
  • the heterogeneity of tumor biology via non-invasive imaging of different portions of the tumor,(The day of the surgery)
  • tumor heterogeneity in artificial intelligence-based imaging reflects and can predict underlying histology (proportion of tumor stroma and density of tumor-infiltrating lymphocytes) (tumor detection and response) and genomics,(The day of the surgery)
  • Correlate MRI results with hematological molecular biology results.(The day of the surgery)

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (2)

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