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

UMC Utrecht

Status: Enrolling

Conditions: Phosphoric Diester Hydrolases; Fluorodeoxyglucose F18; Phosphoric Monoester Hydrolases

Treatments: Diagnostic Test: Deuterium Glucose Metabolic Imaging with MRI spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06232889

DEPLETE

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)