Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To confirm feasibility of DMI for intrahepatic tumor detection.
研究概览
简要总结
Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.
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
- •Adults (≥18 years)
- •Referred for SIRT and deemed eligible by the multidisciplinary tumor board
- •Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake > healthy liver uptake; measurable according to PERCIST)
- •Written informed consent
排除标准
- •Patients having FDG-negative disease (according to PERCIST)
- •Patients with diabetes mellitus
- •Patients having a general contra-indication for SIRT
- •Patients with contra-indications for 7T MR scanning
- •Patient unable to complete study scan (laying still for a long time)
- •Patient unable or incapable to follow study proceedings
结局指标
主要结局
To confirm feasibility of DMI for intrahepatic tumor detection.
时间窗: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.
Image quality comparison between DMI and FDG-PET/CT, defined as technical performance (e.g. signal-to-noise and tumor-to-liver ratios) and intrahepatic lesion detection.
次要结局
未报告次要终点
