Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI
研究概览
简要总结
For cancers, such as mesothelioma, that spread to the lining of the stomach, detecting the cancer is very difficult with CT or MRI scans. Researchers at the University of Chicago want to find out if the new experimental MRI and ultrasound imaging techniques do a better job of detecting these cancers. Researchers will use new MRI and ultrasound techniques to see if it can find evidence of cancer that has spread to the lining of the abdomen, and right now these new techniques are only used for research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 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
- •18 years old or older
- •Biopsy-proven MPM
- •Surgery for PM planned at UCM within 60 days
- •Able to tolerate CT, MRI, US scans, and surgery
- •Able to provide written informed consent
- •For women of child bearing age, ability and willingness to use appropriate contraceptive methods before imaging and for a period of 365 days thereafter.
排除标准
- •Pregnancy / Breastfeeding
- •Allergy or intolerance to iodinated or gadolinum contrast dyes
- •Contraindications to CT or MRI imaging including chronic kidney disease with GFR <60mL/min/1.73m2
- •Bioimplants unsuitable for MRI imaging (activated by mechanical, electronic, radiofrequency, or magnetic means), such as cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps
- •Permanent tattoos or eyeliner with magnetic dyes
- •Subjects with shrapnel or metal fragments lodged in the body
- •Anxiety, claustrophobia, or any medical condition that would preclude lying still in an MRI scanner for 1-1.5 hours
- •Cardiac, circulatory, or perspiration problems leading to impaired thermoregulation
- •Respiratory or cardiac impairment limiting the ability to lie flat
- •Inability to breath-hold for MRI acquisition
- •Vascular or aneurysm clips or any other surgical implant that is not MRI-compatible
- •Any other ferromagnetic bioimplant that would be damaged by MRI
- •Mental, cognitive, or mental health impairments that preclude the subject from providing informed consent or adhering to the treatment protocol
- •Subjects unable to adhere to the protocol or communicate effectively with researchers
- •Imprisoned subjects
- •Subjects with history of prior CRS/HIPEC or other peritonectomy surgery that might alter characteristics of the peritoneum
结局指标
主要结局
Higher Sensitivity for detection using New High Resolution Contrast Enhanced MRI Imaging Sequences compared to standard MRI
时间窗: 60 Days
New HR-MRI sequences will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.
Higher sensitivity for detection of peritoneal metastatic disease using Ultrasound Elastography compared to standard MRI
时间窗: 60 Days
Ultrasound Elastography will demonstrate greater sensitivity than standard MRI for detecting peritoneal metastases.
次要结局
- Test high-definition small-voxel MRI imaging sequences for detection of peritoneal disease in MPM(60 days)
- The performance of diffusion-weighted MRI in detecting peritoneal disease in patients with malignant peritoneal mesothelioma(60 days)
- Perform Ultrasound Elastography in peritoneal mesothelioma to determine elasticity scores(60 days)
- Perform Ultrasound Elastography in peritoneal mesothelioma to determine optimal strain ratios(60 days)