Diagnostic assessment of 18F-fluciclovine (FACBC) - PET/MRI in the evaluation of suspected cerebral gliomas
- Conditions
- GliomasTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2016-000939-41-NO
- Lead Sponsor
- Anna Karlberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients with suspicion of glioma will be included from the Department of Neurosurgery at St. Olavs Hospital. Due to the high cost of the PET tracer, this project will be limited to pre-operative low-and high grade adult glioma patients. Inclusion will start in April 2016 and end in December 2017, and we expect to reach 30 patients by the end of 2017.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
Exclusion criteria will be general contra-indications for PET/MRI, and no ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method