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临床试验/NCT06232889
NCT06232889招募中不适用

Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study

UMC Utrecht2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月1日最近更新:
适应症

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

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

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arthur Braat

Dr. A.J.A.T. Braat

UMC Utrecht

研究点 (2)

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