Trials / Recruiting
RecruitingNCT06232889
Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization
Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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 |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2024-01-31
- Last updated
- 2024-01-31
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06232889. Inclusion in this directory is not an endorsement.