Actively Recruiting
Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
Led by UMC Utrecht · Updated on 2024-01-31
15
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years)
- Referred for Selective Internal Radiation Therapy (SIRT) and deemed eligible by the multidisciplinary tumor board
- At least one liver metastasis ≥1 cm on contrast-enhanced CT or MRI (measurable by RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake greater than healthy liver; measurable by PERCIST)
- Written informed consent
You will not qualify if you...
- FDG-negative disease (per PERCIST criteria)
- Diabetes mellitus
- General contra-indication for SIRT
- Contra-indications for 7T MRI scanning
- Unable to complete study scan (unable to lie still for a long time)
- Unable or incapable to follow study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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