brain tumors MedDRA version: 14.1 Level: LLT Classification code 10061030 Term: Brain tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CHOLINE
CAS Number: 62497
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 370-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: pregnancy/feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to dinstinguish the tumors border from normal brain and to identify the tumour's infiltration for choosing the most appropriate treatment 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 to differentiate between the recurrence from fibrosis/necrosis;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): nd;Timepoint(s) of evaluation of this end point: nd | — |
Countries
Italy
Contacts
Public ContactMedicina Nucleare-Centro PET-TC
Policlinico Gemelli
Outcome results
None listed