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

Not Applicable

Recruiting

• Conditions: Phosphoric Diester Hydrolases; Phosphoric Monoester Hydrolases; Fluorodeoxyglucose F18

• Registration Number: NCT06232889
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands