Glioma, MalignantNCT05896449
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
A study testing [68Ga]Ga-PSMA-11 PET/CT in people with Glioma, Malignant and Glioma Glioblastoma Multiforme, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study was to analyse usefulness of [68Ga]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant, Glioma Glioblastoma Multiforme
- What is being tested?
- [68Ga]Ga-PSMA-11 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2020to 11 Jul 2022
- 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
- primary lesion found in CT/MRI with radiological features of glial neoplasm
- untreated disease, planned surgery
- negative medical history of other neoplastic diseases
- age over 18
- informed, voluntary consent to participate in the study
Who cannot join
- pregnant women, breastfeeding women
- persons with a known allergy to PSMA
- age under 18
- patient's lack of cooperation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Nuclear Medicne Department Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
About this study
The aim of this study was to analyse usefulness of [68Ga]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.
- Conditions
- Glioma, Malignant, Glioma Glioblastoma Multiforme
- Being tested
- [68Ga]Ga-PSMA-11 PET/CT
- Keywords
- glioma, PSMA, PET/CT, [68Ga]Ga-PSMA-11 PET/CT, glial tumours
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PSMA-11 PET/CTDiagnostic test
The PET/CT image acquisition was performed from the skull to the mid-thigh (3-min per bed position, 3 iterations, 21 subsets) with a CT scan (120 kV, 170mAs reference) with dose modulation for anatomic correlation (CARE dose 4D) and attenuation correction on a Biograph 64 TruePoint (Siemens Medical Solutions Inc., USA) 60 min post injection of [68Ga]Ga-PSMA-11 (2 MBq per kg body weight).
| Study group | Role | What they receive |
|---|---|---|
| PET/CT before surgery | Experimental | [68Ga]Ga-PSMA-11 PET/CT before surgery Receives: Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT vs histopathological diagnosis
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with the final histopathological diagnosis based on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021).
The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result).
The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype
Measured: through study completion, an average of 1.5 year
Secondary outcomes (9)
PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis
Comparison of the preoperative [68Ga]Ga-PSMA-11 PET/CT semiquantitative parameters with with the final histopathological diagnosis.
The maximal standard uptake value (SUVmax) of each positive lesion were measured using the spherical volume of interest (VOI).
The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype.
Measured: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis
Comparison of the preoperative [68Ga]Ga-PSMA-11 PET/CT semiquantitative parameters with with the final histopathological diagnosis.
The mean standard uptake value (SUVmean) of each positive lesion were measured using the spherical volume of interest (VOI).
The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype.
Measured: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - TBR vs histopathological diagnosis
Comparison of the preoperative [68Ga]Ga-PSMA-11 PET/CT semiquantitative parameters with with the final histopathological diagnosis.
The Target-to-background ratios (TBR) were calculated using SUVmax of the lesion divided by SUVmax of the background measured using a VOI of a similar diameter, placed in a distant, unaffected region, representing normal brain tissue.
The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype.
Measured: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - TLR vs histopathological diagnosis
Comparison of the preoperative [68Ga]Ga-PSMA-11 PET/CT semiquantitative parameters with with the final histopathological diagnosis.
Target-to-liver background ratios (TLR) were calculated by dividing SUVmax of the lesion by SUVmean of the liver (the liver VOI of a similar diameter placed in the central area of the right liver lobe was used).
The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype.
Measured: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining
Comparison of the preoperative [68Ga]Ga-PSMA-11 PET/CT with the immunohistopathological staining of the tumour tissue.
The maximal standard uptake value (SUVmax) of each positive lesion were measured using the spherical volume of interest (VOI).
The immunoreaction will be analyzed in the endothelium and in tumor cells. A score will be assigned semiquantitatively based on staining intensity and distribution as follows: 0 - negative, 1- faint and weak staining at high power; 2- moderate intensity at low power; and 3- strong reaction at low power.
Measured: through study completion, an average of 1.5 year
PET/CT vs progession free survival time.
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with the progession free survival time.
The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result).
The time will be measured in weeks.
Measured: 1 year after the study
PET/CT vs overall survival time.
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with the overall survival time.
The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result).
The time will be measured in weeks.
Measured: 1 year after the study
PET/CT semiquantitive parameter - SUVmax vs progession free survival time.
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with progession free survival time.
The maximal standard uptake value (SUVmax) of each positive lesion were measured using the spherical volume of interest (VOI).
The time will be measured in weeks.
Measured: 1 year after the study
PET/CT semiquantitive parameter - SUVmax vs overall survival time.
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with the overall survival time.
The maximal standard uptake value (SUVmax) of each positive lesion were measured using the spherical volume of interest (VOI).
The time will be measured in weeks.
Measured: 1 year after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jun 2020
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
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 Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896449
- Sponsor's protocol ID
- WUM-ZMN-05-2023
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pelka K, Koczyk K, Koperski L, Dziedzic T, Nowak A, Krolicki L, Kunert P, Kunikowska J. Imply on diagnosis and early prognosis of preoperative [68Ga]Ga-PSMA-11 PET/CT in patients with suspected brain tumours of glial origin. Sci Rep. 2025 Jan 2;15(1):214. doi: 10.1038/s41598-024-84036-5.
PubMed 39747932
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
- ClinicalTrials.gov ID
- NCT05896449
- Acronym / sponsor ID
- WUM-ZMN-05-2023
- Conditions
- Glioma, Malignant, Glioma Glioblastoma Multiforme
- Keywords
- glioma, PSMA, PET/CT, [68Ga]Ga-PSMA-11 PET/CT, glial tumours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 9 Jun 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.
The aim of this study was to analyse usefulness of [68Ga]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT before surgery | Experimental | Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT[68Ga]Ga-PSMA-11 PET/CT before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary lesion found in CT/MRI with radiological features of glial neoplasm
- untreated disease, planned surgery
- negative medical history of other neoplastic diseases
- age over 18
- informed, voluntary consent to participate in the study
Key exclusion criteria (4 listed)
- pregnant women, breastfeeding women
- persons with a known allergy to PSMA
- age under 18
- patient's lack of cooperation
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 |
|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CTThe PET/CT image acquisition was performed from the skull to the mid-thigh (3-min per bed position, 3 iterations, 21 subsets) with a CT scan (120 kV, 170mAs reference) with dose modulation for anatomic correlation (CARE dose 4D) and attenuation correction on a Biograph 64 TruePoint (Siemens Medical Solutions Inc., USA) 60 min post injection of [68Ga]Ga-PSMA-11 (2 MBq per kg body weight). | Diagnostic test | PET/CT before surgery |
Primary outcome
PET/CT vs histopathological diagnosis
Time frame: through study completion, an average of 1.5 year
Comparison of the incidence of positive preoperative [68Ga]Ga-PSMA-11 PET/CT results with the final histopathological diagnosis based on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021). The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result). The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype
9 secondary outcomes
PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis
Time frame: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis
Time frame: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - TBR vs histopathological diagnosis
Time frame: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - TLR vs histopathological diagnosis
Time frame: through study completion, an average of 1.5 year
PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining
Time frame: through study completion, an average of 1.5 year
PET/CT vs progession free survival time.
Time frame: 1 year after the study
PET/CT vs overall survival time.
Time frame: 1 year after the study
PET/CT semiquantitive parameter - SUVmax vs progession free survival time.
Time frame: 1 year after the study
PET/CT semiquantitive parameter - SUVmax vs overall survival time.
Time frame: 1 year after the study
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 9 Jun 2023.
- Derived from this study: PubMed 39747932Pelka K, Koczyk K, Koperski L, Dziedzic T, Nowak A, Krolicki L, Kunert P, Kunikowska J. Imply on diagnosis and early prognosis of preoperative [68Ga]Ga-PSMA-11 PET/CT in patients with suspected brain tumours of glial origin. Sci Rep. 2025 Jan 2;15(1):214. doi: 10.1038/s41598-024-84036-5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PSMA-11 PET/CT in people with Glioma, Malignant and Glioma Glioblastoma Multiforme, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 4 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 9 Jun 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 Poland. 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?
PET/CT vs histopathological diagnosis (time frame: through study completion, an average of 1.5 year). 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 NCT05896449, 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 9 Jun 2023.