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(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors

NCT05798273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-09-08

No results posted yet for this study

Summary

PSMA is a transmembrane protein specifically expressed in the vascular endothelium of malignant brain tumors, most notably glioblastoma and not in healthy brain parenchyma. It has been shown to be involved in (neo)angiogenesis and endothelial cell invasion. By means of 68Ga-labeled PSMA ligands, investigators are able to non-invasively visualize/quantify PSMA expression in glioblastoma (neo)vasculature in vivo by means of PET.

The primary aim of this study is to confirm PSMA as suitable diagnostic and potential theranostic target in patients with intra-axial brain tumors by means of \[68Ga\]Ga-PSMA-HBEC-CC (\[68Ga\]Ga-PSMA-11) PET.

The secondary aim is to assess whether uptake is increased with intra-arterial injection in those tumors that show uptake after intravenous injection of \[68Ga\]Ga-PSMA-11.

Conditions

  • Malignant Brain Tumors

Interventions

PROCEDURE

intra-arterial injection

All patients will receive an intravenous injection of \[68Ga\]Ga-PSMA-11 (1.5 MBq/kg), followed by a synchronous PET/MRI scan (median duration approximately 50 min) at 45-60 min post-injection. In case of a positive \[68Ga\]Ga-PSMA-PET signal at the tumor site, patients will return (in 2 weeks) for an intra-arterial injection (i.e., a neuro-interventional procedure) of 68Ga-PSMA-11 (1.5 MBq/kg), followed by a repeat synchronous PET/MRI scan (median duration 50 min) at 45-60 min post-injection.

DEVICE

synchronous PET/MRI scan

Scan done at (median duration approximately 50 min) at 45-60 min post-injection.

OTHER

Radiopharmacon Contrast agent

Type: \[68Ga\]Ga-PSMA-11 dosage: 1.5 MBq/kg

Sponsors & Collaborators

Principal Investigators

  • Sophie EM Veldhuijzen van Zante, Dr · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-03-01
Completion
2023-03-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05798273 on ClinicalTrials.gov