Role of diagnostic imaging in the study of gliomas.
Phase 1
- Conditions
- Patients with high-grade glioma (III-IV).MedDRA version: 20.0Level: HLTClassification code 10018339Term: Gliomas benignSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000679-28-IT
- Lead Sponsor
- OSPEDALE SAN RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
- pregnancy and/or breastfeeding
- patients <18years
- inability to perform stereotactic biopsy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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