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

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
18F-PSMA-1007 PET tracer
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma Multiforme focused on measuring nuclear imaging, prostate specific membrane antigen, glioblastoma multiforme, positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-PSMA-1007 PET/CT

Arm Description

Outcomes

Primary Outcome Measures

The uptake of 18F-PSMA PET/CT in suspected GBM lesions

Secondary Outcome Measures

The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT uptake
Correlation between 18F-PSMA PET/CT and T1Gd MRI

Full Information

First Posted
October 8, 2020
Last Updated
January 26, 2021
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04588454
Brief Title
18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme
Acronym
PSMA-GBM
Official Title
18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
nuclear imaging, prostate specific membrane antigen, glioblastoma multiforme, positron emission tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-PSMA-1007 PET/CT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
18F-PSMA-1007 PET tracer
Intervention Description
18F-PSMA-1007 PET/CT
Primary Outcome Measure Information:
Title
The uptake of 18F-PSMA PET/CT in suspected GBM lesions
Time Frame
uptake of the tracer at 2 hours post injection
Secondary Outcome Measure Information:
Title
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
Title
Correlation between 18F-PSMA PET/CT and T1Gd MRI
Time Frame
Uptake of the tracer at 2 hours post injection vs pre-op MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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