Gliomas
Conditions
Interventions
Trade Name: 18F-Fluciclovine
(anti1-amino-3-18F-fluorocyclobutane-1-carboxylic acid ([18]F FACBC))
Product Name: 18F-Fluciclovine
Pharmaceutical Form: Solution for injection
Sponsors
Anna Karlberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall goal is to offer future glioma patients improved diagnostics and treatment, by using PET/MRI in the clinical routine.;Secondary Objective: With a combined PET/MRI examination we expect glioma patients to receive a more accurate diagnosis than with MRI alone. Potential patient benefits will include better selection of biopsy site with higher probability to grade the tumor correctly, better overall knowledge of tumor extent and metabolism and better treatment planning based on more image information. ;Primary end point(s): The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today, and also compare these results with the histopathological diagnosis. ;Timepoint(s) of evaluation of this end point: The clinical MRI will be evaluated as common routine by an experienced neuroradiologist, blinded for the results of the PET and the histopathological diagnosis. The PET examination will be evaluated by an experienced nuclear medicine physician. MRI and PET images will finally be evaluated together by a neuroradiologist and a nuclear medicine physician for a joint PET/MRI description/report. This will be done continously throughout the study. 2016-2017 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Qualitative and quantitative image data will be compared to the histopathological information for evaluation of diagnostic performance. Both the dynamic and static PET images will be evaluated. For semiquantitative analysis of the static PET data SUVmax and tumor-to-background ratios will be calculated. Evaluation of dynamic PET recordings will also be assessed to extract individual time activity curves (TAC) for the kinetic analysis. TAC will be compared for differentiation between low-grade and high-grade gliomas and to study the relationship between the TAC pattern and histology type. Tumor volume calculation/delineation will be compared between PET and MRI. ROC analysis will be used to determine the diagnostic accuracy (and the sensitivity and specificity) of MRI alone versus the combined PET/MRI, for differentiation between non-tumor tissue and tumor tissue and for differentiation between high-grade and low-grade gliomas. Evaluation of biopsy site determined by MRI alone and by combined PET/MRI will also be performed.;Timepoint(s) of evaluation of this end point: 2016-2017 | — |
Countries
Norway
Contacts
Public ContactAnna Karlberg
Anna Karlberg
Outcome results
None listed