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NCT Number: NCT05896449

Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin

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.

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Key information

Conditions

Glioma, Malignant Astrocytoma Glioblastoma Glioma Glioma Glioblastoma Multiforme Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuclear Medicne Department Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • pregnant women, breastfeeding women
  • persons with a known allergy to PSMA
  • age under 18
  • patient's lack of cooperation

Treatment and study plan

[68Ga]Ga-PSMA-11 PET/CT

Diagnostic 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).

Primary outcomes

  1. 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

Secondary outcomes

  1. PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis

    Time frame: through study completion, an average of 1.5 year

    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.

  2. PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis

    Time frame: through study completion, an average of 1.5 year

    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.

  3. PET/CT semiquantitive parameter - TBR vs histopathological diagnosis

    Time frame: through study completion, an average of 1.5 year

    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.

  4. PET/CT semiquantitive parameter - TLR vs histopathological diagnosis

    Time frame: through study completion, an average of 1.5 year

    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.

  5. PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining

    Time frame: through study completion, an average of 1.5 year

    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.

  6. PET/CT vs progession free survival time.

    Time frame: 1 year after the study

    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.

  7. PET/CT vs overall survival time.

    Time frame: 1 year after the study

    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.

  8. PET/CT semiquantitive parameter - SUVmax vs progession free survival time.

    Time frame: 1 year after the study

    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.

  9. PET/CT semiquantitive parameter - SUVmax vs overall survival time.

    Time frame: 1 year after the study

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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