A new PET radiopharmaceutical in Hungary to detect brain tumors
Phase 1
- Conditions
- Primary and secondary brain tumorsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2015-002948-14-HU
- Lead Sponsor
- PET Diagnosztikai Kft.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
histologically confirmed primary or secondary brain tumor
previous MRI study (T1WI, PDWI, T2WI, postcontrast T1WI)
clinical history is available
cooperating patient
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
non-cooperating patient
clinical data are not available
claustrophobia
patient refused participation
pregnancy or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI;Secondary Objective: Quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for assessing prognosis;Primary end point(s): Accessing the clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI.;Timepoint(s) of evaluation of this end point: Evaluation of this endpointDec. 20, 2016
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Testing the applicability of quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for estimating prognosis;Timepoint(s) of evaluation of this end point: Evaluation of this endpointDec. 20, 2016