Role of diagnostic imaging in the study of gliomas.

Prognostic value of 18F-FAZA PET/CT in high grade glioma: comparison with MRI and correlation with hypoxia biomarkers. - FAZA-gliomas

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000679-28-IT

Enrollment

Registered

2021-06-04

Start date

2015-07-13

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Patients with high-grade glioma (III-IV). MedDRA version: 20.0 Level: HLT Classification code 10018339 Term: Gliomas benign System Organ Class: 100000004852

Interventions

Product Name: FAZA Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adult patients - MRI suggestive of the presence of high-grade glioma - indication of the performance of stereotactic biopsy - patients are able to understand the study and release their 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - pregnancy and/or breastfeeding - patients <18years - inability to perform stereotactic biopsy

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the role of PET/CT with 18F-FAZA as a guide to biopsy, to predict patient outcomes, to define the correlation between spatial pseudoprogressione disease / radiation necrosis and hypoxia and to plan radiotherapy treatment in patients with high-grade gliomas.;Secondary Objective: Correlation between MRI and PET data with histopathological data.;Primary end point(s): visual and semiquantitative evaluation of tracer FAZA;Timepoint(s) of evaluation of this end point: 1 DAY	—

Measure

Time frame

Main Objective: To define the role of PET/CT with 18F-FAZA as a guide to biopsy, to predict patient outcomes, to define the correlation between spatial pseudoprogressione disease / radiation necrosis and hypoxia and to plan radiotherapy treatment in patients with high-grade gliomas.;Secondary Objective: Correlation between MRI and PET data with histopathological data.;Primary end point(s): visual and semiquantitative evaluation of tracer FAZA;Timepoint(s) of evaluation of this end point: 1 DAY

—

Secondary

Measure	Time frame
Secondary end point(s): visualize the standard treatment planning based on MRI images with treatment guided by PET images;Timepoint(s) of evaluation of this end point: 1 DAY	—

Countries

Italy

Contacts

Public ContactMEDICINA NUCLEARE

IRCCS OSPEDALE SAN RAFFAELE

picchio.maria@hsr.it02-26436117

Outcome results

None listed

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