Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613841
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Multitracer 18FFluciclovine and 18F-FDG PET and Advanced MRI for Metabolic Profiling of Glioblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study to Evaluate Multitracer 18FFluciclovine and 18F-FDG PET and Advanced MRI Methods At 7Tesla Metabolic Profiling of Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GBM
Brief Summary:
To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer 18FFluciclovine and 18F-FDG PET
To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays RNA seq and proteomics of glutamineglutamate glucose and lactate metabolism
To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla
To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays RNA seq and proteomics of glutamineglutamate glucose and lactate metabolism
To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla
Detailed Description:
Subjects with a new intra-axial brain mass that is consistent with glioblastoma GBM on brain MRI or post-treatment histologically or molecularly proven GBM who are suspected to have progression and are candidates for surgical resection according to standard of care may be eligible for this study
Subjects will undergo approximately 45 minutes of dynamic PETCT scanning after injection of 2 mCi 20 of 18F-Fluciclovine The subject will have a 60-minute break after this initial scan session they will be allowed to get off the scanner during this time and encouraged to stay hydrated and void as necessary Subsequently the subjects will undergo injection of up to 10 mCi of 18F-FDG followed by a static 20-minute scan approximately 60 minutes post injection Subjects will have the option to undergo PETCT imaging with 18F-Fluciclovine and 18F-FDG on separate days as long as the imaging happens within 7 business days An optional 60-minute brain MRI without contrast will also be performed with the 70 Tesla MRI machine The timing of the optional second PET scans will be within 7 business days of the baseline PET scans
Positron emission tomography PETCT imaging will be used to evaluate 18F-fluciclovine and 18F-FDG uptake in treatment naïve and recurrent GBM Brain MR with Chemical Exchange Saturation Transfer CEST and MR spectroscopy MRS will be used to determine the glutamate and lactate levels In addition clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions
Subjects will undergo approximately 45 minutes of dynamic PETCT scanning after injection of 2 mCi 20 of 18F-Fluciclovine The subject will have a 60-minute break after this initial scan session they will be allowed to get off the scanner during this time and encouraged to stay hydrated and void as necessary Subsequently the subjects will undergo injection of up to 10 mCi of 18F-FDG followed by a static 20-minute scan approximately 60 minutes post injection Subjects will have the option to undergo PETCT imaging with 18F-Fluciclovine and 18F-FDG on separate days as long as the imaging happens within 7 business days An optional 60-minute brain MRI without contrast will also be performed with the 70 Tesla MRI machine The timing of the optional second PET scans will be within 7 business days of the baseline PET scans
Positron emission tomography PETCT imaging will be used to evaluate 18F-fluciclovine and 18F-FDG uptake in treatment naïve and recurrent GBM Brain MR with Chemical Exchange Saturation Transfer CEST and MR spectroscopy MRS will be used to determine the glutamate and lactate levels In addition clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None