Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908669
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-07
First Post:
2023-05-15
Brief Title:
Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-05
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:
None
Brief Summary:
This is a feasibility single arm study designed for obtaining early data for optimization and evaluation of the clinical potential for a new MR technique using deuterated glucose The purpose of the study is to investigate whether this technique is useful in metabolic imaging of glioblastoma multiforme GBM and whether radiochemotherapy RCT induced changes in the brain metabolism can be detected and might be predictive for treatment response The study will include 10 patients with histologically verified GBM scheduled for standard RCT Patients will have MRI scan performed before and within 8 weeks after starting RCT The scans will include imaging after oral intake of deuterated glucose so called deuterium metabolic imaging DMI Based on this study the most optimal scanning technique output variables of highest discriminative power with respect to RCT and potential predictive markers for response will be selected for further clinical investigation
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