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

NCT ID: NCT06232889

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Deuterium Glucose Metabolic Imaging with MRI spectroscopy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Arthur Braat

Dr. A.J.A.T. Braat

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMC Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

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

Role: primary

a.j.a.t.braat@umcutrecht.nl

+31887558855

Other Identifiers

DEPLETE

Identifier Type: -

Identifier Source: org_study_id