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

Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06232889
Acronym
DEPLETE
Enrollment
15
Registered
2024-01-31
Start date
2024-01-01
Completion date
2027-01-01
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluorodeoxyglucose F18, Phosphoric Diester Hydrolases, Phosphoric Monoester Hydrolases

Keywords

FDG-PET, 31P spectroscopy, MRI, Deuterium Metabolic Imaging, SIRT, TARE, Radioembolization

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.

Interventions

DIAGNOSTIC_TESTDeuterium 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

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To confirm feasibility of DMI for intrahepatic tumor detection.1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.Image quality comparison between DMI and FDG-PET/CT, defined as technical performance (e.g. signal-to-noise and tumor-to-liver ratios) and intrahepatic lesion detection.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026