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

January 29, 2024 updated by: Arthur Braat, UMC Utrecht

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DEPLETE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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