18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme

NCT ID: NCT04588454

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2021-06-01

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 (0.65 MeV for 18F compared to 1.90 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 PET/CT 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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-PSMA-1007 PET/CT

Group Type: EXPERIMENTAL

18F-PSMA-1007 PET tracer

Intervention Type: OTHER

18F-PSMA-1007 PET/CT

Interventions

18F-PSMA-1007 PET tracer

18F-PSMA-1007 PET/CT

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Suspected GBM on MRI scan
• Scheduled for tumor resection at Radboudumc
• Age ≥18 years

Exclusion Criteria

• Age < 18 years
• Pregnancy or the wish to become pregnant within 6 months
• Creatinine clearance below 40ml/min
• Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.

Reference Type: DERIVED

PMID: 38968568 (View on PubMed)

Other Identifiers

NL64616.091.18

Identifier Type: -

Identifier Source: org_study_id