¿THE NOVEL 68Ga-PSMA THERANOSTIC PET/CT COMPOUND FOR FUNCTIONAL IMAGING OF GLIOMA¿ "IMPIEGO DELL¿INNOVATIVO TRACCIANTE TERANOSTICO 68Ga-PSMA PER L¿IMAGING FUNZIONALE PET/TC DEL GLIOMA "

¿THE NOVEL 68Ga-PSMA THERANOSTIC PET/CT COMPOUND FOR FUNCTIONAL IMAGING OF GLIOMA¿ "IMPIEGO DELL¿INNOVATIVO TRACCIANTE TERANOSTICO 68Ga-PSMA PER L¿IMAGING FUNZIONALE PET/TC DEL GLIOMA " - 68Ga-PSMA-GLIOMI-2016

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001307-68-IT

Enrollment

Registered

2021-06-08

Start date

2017-11-07

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspicion of glioma on the basis of clinical and RM data, where histological confirmation is provided, as is the normal care pathway. MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: [68Ga]-PSMA-HBED-CC Product Code: [68Ga]-PSMA-HBED-CC Pharmaceutical Form: Solution for injection INN or Proposed INN: [68Ga]-PSMA-HBED-CC Current Sponsor code: [68Ga]-PSMA-HBED-CC Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Suspect of glioma lesions based on clinical and MRI features • MRI performed as part of the standard care • Adult age • Pathological confirmation as part of the standard care • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Severe acute co-morbidities • Performance status not eligible for PET/CT • Inability to undergo 68Ga-PSMA PET/CT for any reason

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the capture of 68Ga-PSMA in primitive cerebral lesions, suspected of glioma based on clinical and RM data and candidate for histological characterization.;Secondary Objective: The secondary objective of the study is to evaluate the relationship between the capture of 68Ga-PSMA in gliomas and RM parameters with the same-pathological results (in particular grading) on biopsy or surgical samples;Primary end point(s): •Evaluate 68Ga-PSMA uptake in primary brain lesions suspicious for glioma based on clinical and MRI features and eligible for pathological sampling;Timepoint(s) of evaluation of this end point: time necessary for Subsequent histological characterization	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the capture of 68Ga-PSMA in primitive cerebral lesions, suspected of glioma based on clinical and RM data and candidate for histological characterization.;Secondary Objective: The secondary objective of the study is to evaluate the relationship between the capture of 68Ga-PSMA in gliomas and RM parameters with the same-pathological results (in particular grading) on biopsy or surgical samples;Primary end point(s): •Evaluate 68Ga-PSMA uptake in primary brain lesions suspicious for glioma based on clinical and MRI features and eligible for pathological sampling;Timepoint(s) of evaluation of this end point: time necessary for Subsequent histological characterization

—

Secondary

Measure	Time frame
Secondary end point(s): compare 68Ga-PSMA uptake in glioma to MRI parameters and pathological features;Timepoint(s) of evaluation of this end point: time necessary for Subsequent histological characterization	—

Countries

Italy

Contacts

Public ContactU.O. Medicina Nucleare

AOU di Bologna Policlinico S.Orsola-Malpighi

valentina.ambrosini@aosp.bo.it0512143198

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026