Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Absolute elasticity value of the tumor (kPa) before treatment.
研究概览
简要总结
Pancreatic adenocarcinoma is the most pessimistic digestive cancer in terms of prognosis. Tumor response assessment is crucial, and the recent development of new magnetic resonance imaging sequences, such as high resolution applied to diffusion sequences (Harder et al., 2022) or magnetic resonance elastography (MRE) (Steinkohl et al., 2021), could help address this issue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •CT scan diagnosis of non-metastatic pancreatic cancer on contrast-enhanced thoraco-abdomino-pelvic CT;
- •Adult patient: age ≥ 18 years;
- •Patient affiliated with a social security system or beneficiary of such a system;
- •Patient who has received complete information about the research organization and has signed an informed consent form.
排除标准
- •Patient with a contraindication to MRI.
- •Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code.
- •Pregnant woman, parturient, or breastfeeding mother;
- •Minor (non-emancipated) individual;
- •Adult individual under legal protection (guardianship, curatorship, or judicial safeguard);
- •Adult individual unable to express consent.
- •Person deprived of liberty by a judicial or administrative decision, or person undergoing psychiatric care pursuant to Articles L. 32-12-1 and L. 3213-1 of the French Public Health Code.
研究组 & 干预措施
Patient with a borderline pancreatic lesion
Potential pancreatic resection surgery after chemotherapy.
干预措施: Magnetic resonance elastography (MRE). (Device)
Patient with a resectable pancreatic lesion
Pancreatic resection surgery
干预措施: Magnetic resonance elastography (MRE). (Device)
Patient with a resectable pancreatic lesion
Pancreatic resection surgery
干预措施: High-resolution diffusion sequence in MRI (Device)
Patient with a borderline pancreatic lesion
Potential pancreatic resection surgery after chemotherapy.
干预措施: High-resolution diffusion sequence in MRI (Device)
Patient with locally advanced pancreatic lesion.
Chemotherapy treatment.
干预措施: Magnetic resonance elastography (MRE). (Device)
Patient with locally advanced pancreatic lesion.
Chemotherapy treatment.
干预措施: High-resolution diffusion sequence in MRI (Device)
结局指标
主要结局
Absolute elasticity value of the tumor (kPa) before treatment.
时间窗: Baseline (J0) before treatment
The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries.
Absolute elasticity value of the tumor (kPa) after chemotherapy.
时间窗: 3 months, after chimiotherapy
The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries.
次要结局
- For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the absolute elasticity value of the tumor (kPa).(3 months, after surgery)
- For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) before chimiotherapy.(6 months, after surgery)
- For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) after chimiotherapy..(6 months, after surgery)
- For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s.(3 months, after surgery)
- For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s before chimiotherapy..(6 months, after surgery)
- For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the apparent coefficient diffusion (ADC) in mm²/s after chimiotherapy..(6 months, after surgery)
- Overall survival in years(At the end of the follow-up period (maximum 24 months).)
研究者
LECLERC Julie
Principal Investigator
Central Hospital, Nancy, France