Malignant Brain TumorsNCT05798273
(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors
A study testing intra-arterial injection, synchronous PET/MRI scan and Radiopharmacon Contrast agent in people with Malignant Brain Tumors, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Tumors
- What is being tested?
- intra-arterial injection, synchronous PET/MRI scan and Radiopharmacon Contrast agent
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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
- metallic fragments in or near eyes or blood vessels
- metallic cardiac valve(s)
- a cardiac implantable electronic device (pacemaker, wires, implantable cardioverter-defibrillator (ICD))
- eye implants
- ear or cochlear implants
- a drug pump implant
- a nerve stimulator
- dental fillings and bridges
- artificial joints
- penile implants
- tubal ligation clips
- non-removable piercing
- tattoos containing metal traces
- Known allergic reaction to gadolinium-based contrast agents
- Contra-indications for arterial catheterization:
- Known local infection thrombus or distorted anatomy at the puncture site
- Known severe peripheral vascular disease or femoral artery disease, which makes the femoral approach impossible
- Known severe coagulopathy (spontaneous prolonged PT with an INR > 2.5)
- In case of the use of anticoagulation: an absolute contra-indication to temporarily stop or bridge the anti-coagulation.
- Known severe thrombocytopenia (platelet count 50 x 109/L)
- Allergic reaction to iodine containing contrast agent
- A physical, neurologic or psychological condition preventing the patient to lay still for the duration of the procedure (± 2h)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Laurens Groenendijk
Berkel en Rodenrijs, South Holland, 2651GG
About this study
Official title: [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
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.
Read the detailed description
Brain tumors have a major impact due to both high morbidity and mortality. Primary brain tumors (glioma) have a low incidence (5-7:100,000), but the highest loss of life years compared to other cancer types. Glioblastoma without mutations in the Isocitrate Dehydrogenase gene (IDHwt), are the most frequent and the most aggressive of all primary malignant brain tumors. They account for 48% of all the primary malignant brain tumors and 15% of all primary brain tumors. Treatment consists of resection, radiotherapy and systemic chemotherapy. Nevertheless the current prognosis is still poor with a 1-, 2- and 5-year survival of respectively 40%, 17% and 6%.
Secondary brain tumors (brain metastases) are frequent, occurring in 15% of cancer patients (incidence 50-70:100,000). The prevalence of brain metastases is rising due to better extracranial local cancer control with systemic treatment resulting in more surviving patients with good local tumor control, but with brain metastases.
A recently discovered potential target for (localized) therapy of glioblastoma is PSMA. PSMA was originally found to be specifically expressed in normal prostate, and overexpressed in almost all stages of prostate cancer. In recent years, PSMA was also found to be expressed in tumor-associated (neo)vasculature in many other solid tumors, including glioblastoma.
PSMA is distinct from other vascular targets, such as vascular endothelial growth factor, endoglin, or the integrins involved in the general process of angiogenesis, as these latter are not specific to tumor vasculature. PSMA, in contrast, is not expressed in normal vasculature and is only minimally expressed in a subset of normal glial cells. PSMA therewith represents the most specific (neo)vascular target for glioblastoma currently known.
This specificity makes PSMA an ideal target for delivery of a cytotoxic agent or a radionuclide designed to tumor vasculature destruction. Particularly in intra-axial brain tumors such as glioblastoma, therapeutic targeting of (neo)vasculature is attractive as it may be exposed to a therapeutic agent much more readily than the tumor parenchyma itself, which is protected by the blood-brain barrier.
The primary aim of this first PSMA-PET study performed in the Netherlands is to confirm PSMA as suitable diagnostic and 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.
Eligible for this non-treatment study are patient, aged >18 years old, with enhancing glioma or brain metastases scheduled for (re-)resection. Upon informed consent, patients will undergo intravenous injection of [68Ga]Ga-PSMA-11, followed by synchronously combined PET-MR scans at 45-60 min post-injection to determine [68Ga]Ga-PSMA tumor uptake and dosimetry over time.
Based on the known expression profile of PSMA in glioblastoma, it is expected that significant tumor-uptake will be seen in 50% of included patients. In case the tumor shows significant uptake, patients will subsequently undergo local intra-arterial injection of [ 68Ga]GaPSMA-11, with an interval of two weeks, performed by a trained neuro-interventional radiologist, immediately followed by a repeat PET/MRI scan. Tumor uptake values of each of the scans will be compared to determine the optimal route of administration. [68Ga]Ga-PSMA-11 uptake values of the tumor will be compared to the degree of PSMA expression determined by IHC.
Based on the few studies published thus far, we expect significant expression of PSMA to be present in progressive/recurrent enhancing glioma and brain metastases. We expect approximate 50% positive scans and in these, increased uptake upon intra-arterial injection compared to intravenous injection.
The results of this pilot study will aid in the development of future PSMA-targeting chemo-
/radionuclide therapies for malignant brain tumors. Therapeutic PSMA PET imaging studies have not yet been performed in patients with primary brain tumors, but studies in patients with (cerebral) metastases from prostate cancer show promising clinical results and acceptable toxicity.
- Conditions
- Malignant Brain Tumors
- Being tested
- intra-arterial injection, synchronous PET/MRI scan, Radiopharmacon Contrast agent
- Keywords
- Intra-axial brain tumor Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial injectionProcedure or surgery
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.
synchronous PET/MRI scanDevice
Scan done at (median duration approximately 50 min) at 45-60 min post-injection.
Radiopharmacon Contrast agentOther
Type: [68Ga]Ga-PSMA-11 dosage: 1.5 MBq/kg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intra-arterial injection; Device: synchronous PET/MRI scan; Other: Radiopharmacon Contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor SUV (upon intravenous and intra-arterial injection),
tumor SUV (upon intravenous and intra-arterial injection
Measured: 1 day
SUV tumor-to-background ratio
SUV tumor-to-background ratio
Measured: 1 week
Biodistribution
Biodistribution
Measured: 1 week
correlation between SUV and the degree of immunohistochemical PSMA staining
correlation between SUV and the degree of immunohistochemical PSMA staining
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Sep 2020
- Primary completion1 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Brain TumorsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomized, single center, prospective imaging study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. S.E.M. Veldhuijzen van Zanten, Erasmus Medical Center
- Investigators
- Sophie EM Veldhuijzen van Zante, Dr, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798273
- Sponsor's protocol ID
- ErasmusMC-2020-0338
- Status last verified
- Sep 2023
- First submitted
- 16 Jan 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40414994
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [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
- ClinicalTrials.gov ID
- NCT05798273
- Acronym / sponsor ID
- ErasmusMC-2020-0338
- Conditions
- Malignant Brain Tumors
- Keywords
- Intra-axial brain tumor Malignant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain tumors have a major impact due to both high morbidity and mortality. Primary brain tumors (glioma) have a low incidence (5-7:100,000), but the highest loss of life years compared to other cancer types. Glioblastoma without mutations in the Isocitrate Dehydrogenase gene (IDHwt), are the most frequent and the most aggressive of all primary malignant brain tumors. They account for 48% of all the primary malignant brain tumors and 15% of all primary brain tumors. Treatment consists of resection, radiotherapy and systemic chemotherapy. Nevertheless the current prognosis is still poor with a 1-, 2- and 5-year survival of respectively 40%, 17% and 6%.
Secondary brain tumors (brain metastases) are frequent, occurring in 15% of cancer patients (incidence 50-70:100,000). The prevalence of brain metastases is rising due to better extracranial local cancer control with systemic treatment resulting in more surviving patients with good local tumor control, but with brain metastases.
A recently discovered potential target for (localized) therapy of glioblastoma is PSMA. PSMA was originally found to be specifically expressed in normal prostate, and overexpressed in almost all stages of prostate cancer. In recent years, PSMA was also found to be expressed in tumor-associated (neo)vasculature in many other solid tumors, including glioblastoma.
PSMA is distinct from other vascular targets, such as vascular endothelial growth factor, endoglin, or the integrins involved in the general process of angiogenesis, as these latter are not specific to tumor vasculature. PSMA, in contrast, is not expressed in normal vasculature and is only minimally expressed in a subset of normal glial cells. PSMA therewith represents the most specific (neo)vascular target for glioblastoma currently known.
This specificity makes PSMA an ideal target for delivery of a cytotoxic agent or a radionuclide designed to tumor vasculature destruction. Particularly in intra-axial brain tumors such as glioblastoma, therapeutic targeting of (neo)vasculature is attractive as it may be exposed to a therapeutic agent much more readily than the tumor parenchyma itself, which is protected by the blood-brain barrier.
The primary aim of this first PSMA-PET study performed in the Netherlands is to confirm PSMA as suitable diagnostic and 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.
Eligible for this non-treatment study are patient, aged >18 years old, with enhancing glioma or brain metastases scheduled for (re-)resection. Upon informed consent, patients will undergo intravenous injection of [68Ga]Ga-PSMA-11, followed by synchronously combined PET-MR scans at 45-60 min post-injection to determine [68Ga]Ga-PSMA tumor uptake and dosimetry over time.
Based on the known expression profile of PSMA in glioblastoma, it is expected that significant tumor-uptake will be seen in 50% of included patients. In case the tumor shows significant uptake, patients will subsequently undergo local intra-arterial injection of [ 68Ga]GaPSMA-11, with an interval of two weeks, performed by a trained neuro-interventional radiologist, immediately followed by a repeat PET/MRI scan. Tumor uptake values of each of the scans will be compared to determine the optimal route of administration. [68Ga]Ga-PSMA-11 uptake values of the tumor will be compared to the degree of PSMA expression determined by IHC.
Based on the few studies published thus far, we expect significant expression of PSMA to be present in progressive/recurrent enhancing glioma and brain metastases. We expect approximate 50% positive scans and in these, increased uptake upon intra-arterial injection compared to intravenous injection.
The results of this pilot study will aid in the development of future PSMA-targeting chemo-
/radionuclide therapies for malignant brain tumors. Therapeutic PSMA PET imaging studies have not yet been performed in patients with primary brain tumors, but studies in patients with (cerebral) metastases from prostate cancer show promising clinical results and acceptable toxicity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized, single center, prospective imaging study.
| Arm | Type | Receives |
|---|---|---|
| intra-arterial injection of [68Ga]Ga-PSMA-11 | Other | Procedure: intra-arterial injection, Device: synchronous PET/MRI scan, Other: Radiopharmacon Contrast agenteligible for intra-arterial injection (age >18 years) with enhancing glioma or brain metastases eligible for (re-)resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Radiologically presumed/histologically confirmed.
- glioma (grade II-IV) showing enhancement on post-contrast MRI
- brain metastases
- Planned for (re-)resection
- Age > 18 years old
Key exclusion criteria (37 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial injectionAll 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. | Procedure or surgery | intra-arterial injection of [68Ga]Ga-PSMA-11 |
| synchronous PET/MRI scanScan done at (median duration approximately 50 min) at 45-60 min post-injection. | Device | intra-arterial injection of [68Ga]Ga-PSMA-11 |
| Radiopharmacon Contrast agentType: [68Ga]Ga-PSMA-11 dosage: 1.5 MBq/kg | Other | intra-arterial injection of [68Ga]Ga-PSMA-11 |
Primary outcome
tumor SUV (upon intravenous and intra-arterial injection),
Time frame: 1 day
tumor SUV (upon intravenous and intra-arterial injection
SUV tumor-to-background ratio
Time frame: 1 week
SUV tumor-to-background ratio
Biodistribution
Time frame: 1 week
Biodistribution
correlation between SUV and the degree of immunohistochemical PSMA staining
Time frame: 1 week
correlation between SUV and the degree of immunohistochemical PSMA staining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 40414994Pruis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie EM Veldhuijzen van Zante, Dr principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-arterial injection, synchronous PET/MRI scan and Radiopharmacon Contrast agent in people with Malignant Brain Tumors, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor SUV (upon intravenous and intra-arterial injection), (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.