Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588454
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2020-10-08
Brief Title:
18F-PSMA PETCT for Visualization of Glioblastoma Multiforme
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
18F-PSMA PETCT for Visualization of Glioblastoma Multiforme
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PSMA-GBM
Brief Summary:
This is a pilot study to determine uptake of PET tracer 18F-PSMA-1007 in primary glioblastoma
Detailed Description:
Glioblastoma multiforme GBM is a highly vascularised tumour Previous studies have shown that prostate-specific membrane antigen PSMA is robustly expressed by the tumour vascular endothelium of GBM and thus could be an interesting target for diagnosis and treatment
Several groups have focused on the development of 18F-labeled PSMA ligands for PET imaging 18F as a radionuclide has several advantages over 68Ga Due to the longer half-life compared 110 min for 18F compared to 68 min for 68Ga allows for centralized production and distribution to greater areas Furthermore multiple doses of 18F can be produced in one synthesis while each gallium generator provides only one or two elutions per day Moreover due to the decreased positron energy 065 MeV for 18F compared to 190 MeV for 68Ga imaging resolution may be higher The first generation of 18F-PSMA ligands such as 18F-DCFBC suffered from high background due to slow blood clearance The second generation 18F-DCFPyL PSMA ligand has a fast elimination via the urinary route and showed high tumor-to-blood ratios Benesova et al developed the 177Lu-DKFZ-61 which is suitable for labelling with both diagnostic 68Ga as well as therapeutic 177Lu beta-emitting or 225Ac alpha-emitting and Giesel at al developed 18F-PSMA-1007 which is structurally related to DKZF-617
Since various studies have shown feasibility of PSMA imaging in brain lesions of patients with recurrent GBM we want to extend these results in a cohort of patients with a first-diagnosed suspected GBM We want to use the PET tracer 18F-PSMA-1007 If this technique can be implemented successfully the added value of 18F-PSMA PETCT for tumour grading and differential diagnosis could be investigated further in larger patient cohorts especially with recurrent brain lesions These studies will pave the way for further studies involving 177Lu-PSMA-based therapy which is currently applied in patients with metastatic prostate cancer
Several groups have focused on the development of 18F-labeled PSMA ligands for PET imaging 18F as a radionuclide has several advantages over 68Ga Due to the longer half-life compared 110 min for 18F compared to 68 min for 68Ga allows for centralized production and distribution to greater areas Furthermore multiple doses of 18F can be produced in one synthesis while each gallium generator provides only one or two elutions per day Moreover due to the decreased positron energy 065 MeV for 18F compared to 190 MeV for 68Ga imaging resolution may be higher The first generation of 18F-PSMA ligands such as 18F-DCFBC suffered from high background due to slow blood clearance The second generation 18F-DCFPyL PSMA ligand has a fast elimination via the urinary route and showed high tumor-to-blood ratios Benesova et al developed the 177Lu-DKFZ-61 which is suitable for labelling with both diagnostic 68Ga as well as therapeutic 177Lu beta-emitting or 225Ac alpha-emitting and Giesel at al developed 18F-PSMA-1007 which is structurally related to DKZF-617
Since various studies have shown feasibility of PSMA imaging in brain lesions of patients with recurrent GBM we want to extend these results in a cohort of patients with a first-diagnosed suspected GBM We want to use the PET tracer 18F-PSMA-1007 If this technique can be implemented successfully the added value of 18F-PSMA PETCT for tumour grading and differential diagnosis could be investigated further in larger patient cohorts especially with recurrent brain lesions These studies will pave the way for further studies involving 177Lu-PSMA-based therapy which is currently applied in patients with metastatic prostate cancer
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