Feasibility of Electromagnetic Acoustic Imaging of Liver Tumours - A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EMA (colour scale) images will be compared to baseline US grey-scale images for a specific target lesion, as determined by standard of care imaging (US, CT, MRI or PET) and/or histologically proven lesion in a given subject.
研究概览
简要总结
A single-centre, industry sponsored, proof-of-concept pilot study to assess the feasibility of Electromagnetic Acoustic Imaging (EMA) as an imaging platform in the visualization of hepatic tumours.
详细描述
STUDY DESIGN Population Single centre pilot study enrolling 30 patients. The study population will comprise of adult patients with documented and characterized focal liver lesion(s) (malignant and/or benign) based on imaging performed at Sunnybrook Health Sciences Centre.
Target lesions and background liver to be studied include:
- Malignant tumours (metastases (adenocarcinomas and neuroendocrine tumours) and primary hepatic malignancy)
- Benign tumours (haemangiomas, focal nodular hyperplasia and adenomas)
- Background liver (remote from target lesion), both normal and fatty liver parenchyma will be included.
Participants must meet the strict inclusion/exclusion criteria for study participation.
Enrollment
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
- •Diagnostic liver imaging (US, CT or MRI) prior to enrolment demonstrating characteristic (benign or malignant) focal liver lesion with classic imaging features or focal liver lesion that will undergo histopathological analysis (percutaneous biopsy or surgical resection) following EMA imaging.
- •Focal liver lesion ≥ 1.5cm
- •Pre-determined focal liver lesion in location likely easily visible on US
- •Ability to provide written informed consent to participate in the study
排除标准
- •Pregnant or possibility of pregnancy
- •Cardiac pacemaker implanted cardioverter- defibrillator, neuro-stimulation system, hepatobiliary metallic foreign body or tattoo at proposed site of imaging.
- •Indeterminate focal liver lesion by conventional US, CT and/or MRI imaging and without the prospect of histopathological assessment of lesion(s)
- •Local and/or systemic treatment related to focal liver lesion, prior to EMA imaging.
- •Inability to obtain imaging and/or acceptable quality of grey-scale and/or EMA imaging
研究组 & 干预措施
Electromagnetic Acoustic Imaging
干预措施: Electromagnetic Acoustic Imaging (Device)
结局指标
主要结局
EMA (colour scale) images will be compared to baseline US grey-scale images for a specific target lesion, as determined by standard of care imaging (US, CT, MRI or PET) and/or histologically proven lesion in a given subject.
时间窗: 18 months
EMA (colour scale) images will be compared to baseline US grey-scale images for a specific target lesion, as determined by standard of care imaging (US, CT, MRI or PET) and/or histologically proven lesion in a given subject. EMA colour maps and fused EMA colour with grey-scale US imaging will be assigned a binary outcome for lesion detection (yes/no) and positive results will be graded along a categorical incremental scale with respect to level of EMA signal (i.e. 0 (no signal), 1 (minimal signal), 2 (mild signal) to 5 (good)). Expert readers in diagnostic imaging will obtained outcome measures visually.
次要结局
- US grey-scale and EMA colour maps will be obtained from both target liver lesions and background liver tissue from the same subject and compared.(18 months)