[68Ga]Ga-PSMA-11 PET/MR-imaging of malignant intra-axial brain tumors; primary assessment of PSMA expression, optimization of compound delivery and determination of theranostic potential.

[68Ga]Ga-PSMA-11 PET/MR-imaging of malignant intra-axial brain tumors; primary assessment of PSMA expression, optimization of compound delivery and determination of theranostic potential. - [68Ga]Ga-PSMA-11 PET/MR-imaging of malignant intra-axial brain tumors.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49568

Enrollment

Registered

2020-07-10

Start date

2021-03-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant intra-axial primary brain tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - Impaired renal function: eGFR (MDRD) = 2.5 x 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 - Contra-indications for arterial catheterization

Design outcomes

Primary

Measure	Time frame
The main study endpoints are the tumor SUV (upon intravenous and local intra-arterial injection), the SUV tumor-to-background ratio, [68Ga]Ga-PSMA-11 biodistribution, the correlation between the SUV and the degree of immunohistochemical PSMA expression of the tumor.	—

Secondary

Measure	Time frame
Semi-quantitative comparison of tracer uptake in the tumor upon intravenous versus local intra-arterial injection of [68Ga]Ga-PSMA-11.	—

Countries

Netherlands

Outcome results