Patients with clinically- suspected glioma
Conditions
Sponsors
Nihon Medi-Physics Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with diagnosed as suspected low/high-grade glioma by the clinical sign/course and MRI exam and scheduled for the surgical resection of the tumor.
Exclusion criteria
Exclusion criteria: -Patients who had received or under treatment of glioma or had received needle biopsy for diagnosis. -Patients who had received chemotherapy for malignant tumor within the last 5 years. -Patients who are pregnant, lactating or possibly pregnant. -Patients who have hepatic or renal dysfunction. -Patients with Karnofsky Performance Status below 50.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy: positive-predictive value of PET imaging in the regions which are not visualized clearly by contrast T1-weighted MRI Safety: subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Efficacy: sensitivity and specificity of NMK36-PET for collected samples, semiquantitative index to detect tumor-extent, inter-reader concordance rate for the reading of NMK36 images, the rate that NMK36-PET contributes to decide or changes the area of tumor-resection, comparison of pathological findings between the regions which NMK36-PET visuallized or not, rate of patients with diagnosed as histopathologically high-grade glioma in patients with suspected low-grade glioma | — |
Countries
Japan
Outcome results
None listed