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18F-FECh-PET in patients with brain tumors

Conditions
brain tumors
MedDRA 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
NameTimeMethod
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
NameTimeMethod
Secondary end point(s): nd;Timepoint(s) of evaluation of this end point: nd
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