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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588454
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
This is a pilot study to determine uptake of PET tracer 18F-PSMA-1007 in primary glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Other: 18F-PSMA-1007 PET tracer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme
Actual Study Start Date : January 17, 2020
Actual Primary Completion Date : October 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-PSMA-1007 PET/CT Other: 18F-PSMA-1007 PET tracer
18F-PSMA-1007 PET/CT




Primary Outcome Measures :
  1. The uptake of 18F-PSMA PET/CT in suspected GBM lesions [ Time Frame: uptake of the tracer at 2 hours post injection ]

Secondary Outcome Measures :
  1. The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT uptake [ Time Frame: uptake of the tracer at 2 hours post injection vs RNA expression determined from excised tumor tissue ]
  2. Correlation between 18F-PSMA PET/CT and T1Gd MRI [ Time Frame: Uptake of the tracer at 2 hours post injection vs pre-op MRI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588454


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04588454    
Other Study ID Numbers: NL64616.091.18
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
nuclear imaging
prostate specific membrane antigen
glioblastoma multiforme
positron emission tomography
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue