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

NCT05798273 | Completed

• 1 other identifier: ErasmusMC-2020-0338
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intra-axial brain tumor Malignant

Outcome Measures

Primary Outcomes (4)

• tumor SUV (upon intravenous and intra-arterial injection),

  tumor SUV (upon intravenous and intra-arterial injection

  1 day

• SUV tumor-to-background ratio

  SUV tumor-to-background ratio

  1 week

• Biodistribution

  Biodistribution

  1 week

• correlation between SUV and the degree of immunohistochemical PSMA staining

  correlation between SUV and the degree of immunohistochemical PSMA staining

  1 week

Study Arms (1)

intra-arterial injection of [68Ga]Ga-PSMA-11

OTHER

eligible for intra-arterial injection (age \>18 years) with enhancing glioma or brain metastases eligible for (re-)resection.

Procedure: intra-arterial injection; Device: synchronous PET/MRI scan; Other: Radiopharmacon Contrast agent

Interventions

intra-arterial injection PROCEDURE

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.

intra-arterial injection of [68Ga]Ga-PSMA-11

synchronous PET/MRI scan DEVICE

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

intra-arterial injection of [68Ga]Ga-PSMA-11

Radiopharmacon Contrast agent OTHER

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

intra-arterial injection of [68Ga]Ga-PSMA-11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologically presumed/histologically confirmed.
• glioma (grade II-IV) showing enhancement on post-contrast MRI
• brain metastases
• Planned for (re-)resection
• Age \> 18 years old
• Good clinical condition (Karnofsky performance status score \>70)
• Ability and willingness to provide written informed consent

You may not qualify if:

• Impaired renal function: eGFR (MDRD) \<30 ml/min/1,73 m2
• Impaired liver function :AST and ALT \> 2.5 8 ULN
• Karnofsky Performance score of less than 70
• Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 3 years prior to enrollment, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
• Known history of cerebrovascular disease (e.g. ischemic stroke, cerebral hemorrhage)
• Severe claustrophobia prohibiting PET/MRI scanning
• A neurologic or psychiatric condition impairing judgement, making adequate informed consent impossible
• Any psychological, familial, sociological or geographical condition hampering participation
• Contra-indications for PET imaging
• Pregnancy or lactation
• Known allergic reaction to therapeutic radiopharmaceuticals
• Contra-indications for MR imaging:
• Metal implants or fragments of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field:
• metal plates, wires, screws or rods
• surgical (brain) clips or staples

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Laurens Groenendijk

Berkel en Rodenrijs, South Holland, 2651GG, Netherlands

Location

Related Publications (1)

• Pruis IJ, van Dis V, Maas SLN, Balvers RK, van den Bosch TPP, Segbers M, Veldhuijzen van Zanten SEM. PSMA radioligand uptake correlates with PSMA expression in high-grade glioma and brain metastasis: insights from a prospective PET-MRI guided multiregional biopsy study. Eur J Nucl Med Mol Imaging. 2025 Nov;52(13):4870-4881. doi: 10.1007/s00259-025-07338-4. Epub 2025 May 26.

  PMID: 40414994 DERIVED

MeSH Terms

Interventions

Injections, Intra-Arterial

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sophie EM Veldhuijzen van Zante, Dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific investigator

Model Details: non-randomized, single center, prospective imaging study.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: April 4, 2023
• Study Start: September 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 31, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)