[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.

Recruiting

Conditions: malignant intra-axial primary brain tumors
brain metastases
10027655

Registration Number: NL-OMON49568

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

- Impaired renal function: eGFR (MDRD) <30 ml/min/1,73 m2
- Impaired liver function: AST and ALT >= 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoints are the tumor SUV (upon intravenous and local<br /><br>intra-arterial injection), the SUV tumor-to-background ratio, [68Ga]Ga-PSMA-11<br /><br>biodistribution, the correlation between the SUV and the degree of<br /><br>immunohistochemical PSMA expression of the tumor.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Semi-quantitative comparison of tracer uptake in the tumor upon intravenous<br /><br>versus local intra-arterial injection of [68Ga]Ga-PSMA-11. </p><br>