Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
研究概览
简要总结
The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
详细描述
Background: Pancreatic cancer is the 8th more common cancer in the world. At diagnosis, majority of patients present with unresectable locally advanced disease. Standard of care therapy for locally advanced pancreatic cancer includes chemotherapy ± radiation therapy. It is published that computed tomography underestimate the effectiveness of neoajuvant treatment and there is a lack of criteria allowing identifying the responders. The misinterpretation of scans may be linked to the large desmoplatic reaction, present in pancreatic cancer, which would not be expected to regress. PET-MR is an imaging technique that associates PET and MR imaging, performed during the same examination. The main hypothesis is that PET-MR imaging could accurately identify resectable and no resectable pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Primary aim Assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy
Secondary aims Assess the accuracy of quantitative PET-MRI parameters to predict resectability and response of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy Compare accuracy of PET-MRI and CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Assess inter and intra observer reproducibility of PET-MRI reading CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Number of subjects 125 Number of centers 8
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
- 否
入选标准
- •Age > 18yo
- •Locally advanced or borderline resectable pancreatic adenocarcinoma, according to the NCCN classification
- •Eligible for neoadjuvant chemotherapy ± radiation therapy, according to the local tumor board
- •With contraception if fertile woman
- •With informed consent obtained
- •Affiliated to French health care system
排除标准
- •Previous treatment for the pancreatic adenocarcinoma
- •Metastases
- •Contra-indication to MRI acquisition (pace maker, metallic device, ..)
- •Contra-indication to PET acquisition (non controlled diabetes with glycaemia > 11 mmol/L)
- •Pregnancy or breast feeding
- •Patient unable to give his consent
研究组 & 干预措施
PET/MRI
PET/MRI examination
干预措施: PET/MRI (Device)
结局指标
主要结局
Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
时间窗: PET/MRI performed less than one month before the surgery
次要结局
- Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for response evaluation(PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery)
- Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for resectability(PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery)
- Comparison of the accuracies of PT MRI and CT for resectability assessment(CT and PET MRI performed less than one month before the surgery)