Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization

Recruiting now · Not applicable

Conditions studied: Fluorodeoxyglucose F18, Phosphoric Monoester Hydrolases, Phosphoric Diester Hydrolases

In brief

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.

Key facts

Study ID

NCT06232889

Run by

UMC Utrecht

People needed

15

Starts

2024-01-01

Expected to finish

2027-01-01

Last updated by the study team

2024-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UMC Utrecht — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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