meningioma
Conditions
Interventions
Prior to surgery, a MET-PET scan is taken, and using surgical navigation, the areas of high MET-PET concentration that are not depicted as contrast lesions in pre-surgical MRI images are excised to ev
Sponsors
Matsuda Masahide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible 1) Patients undergoing surgical removal of a first or recurrent (regardless of prior treatment, any number of recurrences are acceptable) brain tumor with meningioma as the primary differential 2) Patients scheduled for maximal resection by surgery (excluding biopsy, etc.) 3) Age 18 years or older on the date of consent, regardless of gender 4) Tumor invasion into the surrounding area is suspected due to either (1) or (2) below 1. Most suspicious for recurrent meningioma 2. One or more of the following imaging findings on preoperative imaging: infiltration of the surrouding brain or bone, hyperostosis or bony destruction of the surrounding skull, extracranial extension of the tumor, marked cerebral edema around the tumor, cystic change within or around the tumor, irregularity oh the tumor border, presence of peritumoral satellite lesions 5) Patients who have received sufficient explanation and understanding of the contents of this study, and who have given written consent of their own free will (substitute consent is not permitted, but substitute writing is permitted for patients who have difficulty writing due to paralysis, etc.)
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will not be included in this study 1) Patients with serious conditions or complications of systemic diseases that may interfere with the safe performance of general anesthesia or craniotomy 2) Patients who are unable to undergo contrast-enhanced MRI 3) Patients with poorly controlled diabetes 4) Patients with a history of myocardial infarction 5) Patients with unstable angina 6) Patients with serious liver disease or liver enzyme abnormalities [AST (GOT) or ALT (GPT) 100U/L or higher] 7) Patients with serious renal dysfunction (blood urea nitrogen 25mg/dL or higher or serum creatinine 2.0mg/dL or higher) 8) Positive for HBs antigen, HCV antibody, or HIV antibody 9) Woman who are pregnant or may become pregnant 10) Woman who are breastfeeding 11) Patients who have received any other study drug or investigational drug within 3 months of the scheduled administration of the study drug 12) Other patients who are judged by the principal investigator to be ineligible as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases in which MET-PET could preoperatively predict areas of tumor infiltration that were not visible on contrast-enhanced MRI as MET high-accumulation regions | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of cases with MET-PET high accumulation area not contrasted on MRI Tumor positivity rate in non-contrasted specimens extracted based on MET-PET high accumulation index Positive predictive value of tumor in each of the following areas: dural invasion, bone invasion, soft tissue invasion, and brain invasion Correlation between MET-PET accumulation threshold and tumor positive predictive value Correlation between MET-PET accumulation and pathological findings Correlation between MRI findings and MET-PET accumulation Evaluation of molecular profiles associated with MET-PET accumulation | — |
Contacts
Public ContactMasahide Matsuda
University of Tsukuba Hospital
Outcome results
None listed