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NCT Number: NCT06232889

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3508 GA, Netherlands

Location status: Recruiting

Location contact

Arthur J.A.T. Braat, M.D. Ph.D.

CONTACT

[email protected]

+31887558855

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deuterium Glucose Metabolic Imaging with MRI spectroscopy

Diagnostic Test

MRI spectroscopy of the liver, following ingestion of 20 mg deuterium glucose p.o., prior to and after radioembolization treatment for mCRC

Primary outcomes

  1. To confirm feasibility of DMI for intrahepatic tumor detection.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Acronym: DEPLETE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.