Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deuterium Glucose Metabolic Imaging with MRI spectroscopy.
- Who it may be relevant to
- Registry conditions: Fluorodeoxyglucose F18, Phosphoric Monoester Hydrolases, Phosphoric Diester Hydrolases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
Overview
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.
Interventions
- Diagnostic test Deuterium Glucose Metabolic Imaging with MRI spectroscopy
MRI spectroscopy of the liver, following ingestion of 20 mg deuterium glucose p.o., prior to and after radioembolization treatment for mCRC
Primary outcome measures
- To confirm feasibility of DMI for intrahepatic tumor detection. [Time frame: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- UMC Utrecht — Utrecht
Identifiers
NCT: NCT06232889 · DEPLETE