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.

Study Overview

• Status: Completed
• Conditions: Glioma, Malignant; Glioma Glioblastoma Multiforme
• Intervention / Treatment: Diagnostic test: [68Ga]Ga-PSMA-11 PET/CT

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-091
      • Nuclear Medicne Department Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PET/CT before surgery; [68Ga]Ga-PSMA-11 PET/CT before surgery

Diagnostic test: [68Ga]Ga-PSMA-11 PET/CT; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	1 year after the study

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PET/CT; glioma; PSMA; [68Ga]Ga-PSMA-11 PET/CT; glial tumours
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: WUM-ZMN-05-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: reasoned request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No