Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06232889

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

Led by UMC Utrecht · Updated on 2024-01-31

15

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years)
  • Referred for Selective Internal Radiation Therapy (SIRT) and deemed eligible by the multidisciplinary tumor board
  • At least one liver metastasis ≥1 cm on contrast-enhanced CT or MRI (measurable by RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake greater than healthy liver; measurable by PERCIST)
  • Written informed consent
Not Eligible

You will not qualify if you...

  • FDG-negative disease (per PERCIST criteria)
  • Diabetes mellitus
  • General contra-indication for SIRT
  • Contra-indications for 7T MRI scanning
  • Unable to complete study scan (unable to lie still for a long time)
  • Unable or incapable to follow study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UMC Utrecht

Utrecht, Netherlands, 3508 GA

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

0

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