Deuterium Metabolic MRI and [18F]-flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization of Liver Metastasis; pilot study,

Radioembolization, a.k.a. 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 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.

Primary objective: To assess feasability of DMI for intrahepatic tumor
detection.

Secondary objectives:
- Head-to-head comparison between DMI and FDG-PET/CT for intrahepatic tumor
detection.
- Assessment of requirements for spatial resolution and motion correction for
DMI
- Confirm safety and feasibility of DMI and 31P MRSI in clinical practice
- Investigate the potential of DMI and 31P MRSI derived parameters (imaging
biomarkes) for early response prediction to trans-arterial radioembolization
- Determine the most relevant time point for response assessment during
clinical follow-up (1 or 3 months after treatment)

Pilot study, open-label, non-invasive, diagnostic study.

Patients will receive SIRT in clinical care, and the diagnostic, non-invasive
intervention in this study will be added to routine clinical care, having no
influence on treatment management. Subjects will get a 7T MRI scan thrice,
which will take max. 120 min. Before or during the scan, they will receive an
oral dose of deuterated glucose (20 g) dissolved in water. Deuterium (2H) is a
stable, non-radioactive, isotope of hydrogen, and biologically, deuterated
glucose behaves identical to normal glucose.To avoid potential hyperglycemic
complications, patients suffering from diabetes mellitus are not allowed to
participate. No adverse effects have been observed with oral administration of
deuterated glucose at the dosage which will be used in this study. No other
burden or risks are expected. Subjects will not experience direct benefits by
participating in this study. However data gathered from this study may have an
impact on current clinical routine, mainly defining the best time point of
response assessment following SIRT. Additionally, data derived from this study
will be (re)used for subsequent phase 2 imaging studies on 7T MRI scan.