NCT05896449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

May 17, 2023

Last Update Submit

May 29, 2023

Conditions

Glioma, MalignantGlioma Glioblastoma Multiforme

Keywords

gliomaPSMAPET/CT[68Ga]Ga-PSMA-11 PET/CTglial tumours

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis

    through study completion, an average of 1.5 year

  • PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis

    through study completion, an average of 1.5 year

  • PET/CT semiquantitive parameter - TBR vs histopathological diagnosis

    through study completion, an average of 1.5 year

  • PET/CT semiquantitive parameter - TLR vs histopathological diagnosis

    through study completion, an average of 1.5 year

  • PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining

    through study completion, an average of 1.5 year

  • +4 more secondary outcomes

Study Arms (1)

PET/CT before surgery

EXPERIMENTAL

\[68Ga\]Ga-PSMA-11 PET/CT before surgery

Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT

Interventions

[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).

PET/CT before surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear Medicne Department Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (1)

  • 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.

    PMID: 39747932DERIVED

MeSH Terms

Conditions

GliomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 9, 2023

Study Start

June 1, 2020

Primary Completion

July 11, 2022

Study Completion

July 11, 2022

Last Updated

June 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
5 years
Access Criteria
reasoned request

Locations

PL(1)