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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05896449
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Warsaw
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Poland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Malignant, Glioma Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: PET/CT before surgery

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

Interventions

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).

Contact a Trial Team

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International Sites

Warsaw, Mazowieckie, Poland

Status

Address

Nuclear Medicne Department Medical University of Warsaw

Warsaw, Mazowieckie, 02-091