18F-FECh-PET in patients with brain tumors
- Conditions
- brain tumorsMedDRA version: 14.1Level: LLTClassification code 10061030Term: Brain tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-003227-35-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
patients with brain tumours at first diagnosis or with suspicion of recurrence after treatment
age 18-75 years
Patients who provide the written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 10
Exclusion Criteria
pregnancy/feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to dinstinguish the tumors border from normal brain and to identify the tumour's infiltration for choosing the most appropriate treatment<br>to differentiate between the recurrence from fibrosis/necrosis;Secondary Objective: nd;Primary end point(s): to dinstinguish the tumors border from normal brain and to identify the tumour's infiltration for choosing the most appropriate treatment<br>to differentiate between the recurrence from fibrosis/necrosis;Timepoint(s) of evaluation of this end point: 1 day
- Secondary Outcome Measures
Name Time Method Secondary end point(s): nd;Timepoint(s) of evaluation of this end point: nd