NCT06232889 Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
| NCT ID | NCT06232889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Fluorodeoxyglucose F18 |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-01-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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