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

NCT ID: NCT05896449

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma, Malignant Glioma Glioblastoma Multiforme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PET/CT before surgery

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

Group Type EXPERIMENTAL

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

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nuclear Medicne Department Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39747932 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WUM-ZMN-05-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68Ga-NOTA-RM26 PET/CT in Glioma Patients
NCT06412952 RECRUITING EARLY_PHASE1