Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232889
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-12
Brief Title:
Deuterium Metabolic MRI and 18FFDG PET for Assessment of Treatment Response Following Radioembolization
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Deuterium Metabolic MRI and 18F-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPLETE
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-PETCT 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-PETCT 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-PETCT 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 eg 31P MRSI and more importantly the application of Deuterium Metabolic Imaging DMI with non-radioactive deuterated glucose as a potential alternative over FDG-PETCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None