CompletedNot Applicable

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

Netherlands12 participantsStarted 2020-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 * surgic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 day

SUV tumor-to-background ratio

Timeframe: 1 week

Biodistribution

Timeframe: 1 week

correlation between SUV and the degree of immunohistochemical PSMA staining

Timeframe: 1 week

Trial details

NCT IDNCT05798273

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More Malignant Brain Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.