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

NCT06232889 | Recruiting

• 1 other identifier: DEPLETE
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluorodeoxyglucose F18; Phosphoric Monoester Hydrolases; Phosphoric Diester Hydrolases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To confirm feasibility of DMI for intrahepatic tumor detection.

  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.

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A.J.A.T. Braat

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

NL (1)