Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
Primary Purpose
Glioma, Malignant, Glioma Glioblastoma Multiforme
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
[68Ga]Ga-PSMA-11 PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma, Malignant focused on measuring glioma, PSMA, PET/CT, [68Ga]Ga-PSMA-11 PET/CT, glial tumours
Eligibility Criteria
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
Sites / Locations
- Nuclear Medicne Department Medical University of Warsaw
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT before surgery
Arm Description
[68Ga]Ga-PSMA-11 PET/CT before surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05896449
First Posted
May 17, 2023
Last Updated
May 29, 2023
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT05896449
Brief Title
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
Official Title
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
July 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Malignant, Glioma Glioblastoma Multiforme
Keywords
glioma, PSMA, PET/CT, [68Ga]Ga-PSMA-11 PET/CT, glial tumours
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT before surgery
Arm Type
Experimental
Arm Description
[68Ga]Ga-PSMA-11 PET/CT before surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
[68Ga]Ga-PSMA-11 PET/CT
Intervention Description
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 Outcome Measure Information:
Title
PET/CT vs histopathological diagnosis
Description
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
Time Frame
through study completion, an average of 1.5 year
Secondary Outcome Measure Information:
Title
PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
PET/CT semiquantitive parameter - TBR vs histopathological diagnosis
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
PET/CT semiquantitive parameter - TLR vs histopathological diagnosis
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
PET/CT vs progession free survival time.
Description
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.
Time Frame
1 year after the study
Title
PET/CT vs overall survival time.
Description
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.
Time Frame
1 year after the study
Title
PET/CT semiquantitive parameter - SUVmax vs progession free survival time.
Description
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.
Time Frame
1 year after the study
Title
PET/CT semiquantitive parameter - SUVmax vs overall survival time.
Description
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.
Time Frame
1 year after the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nuclear Medicne Department Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-091
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
5 years
IPD Sharing Access Criteria
reasoned request
Learn more about this trial
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
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