Randomized open multicenter study to assess efficacy (for patient outcome) and safety of a single dose (i.v.) of NMK36 in patients with clinically- suspected glioma
- Conditions
- Patients with clinically- suspected glioma
- Registration Number
- JPRN-jRCT2080222933
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
The results of the efficacy evaluation showed that the %9mo-PFS in the NMK36 administration group in the suspected high-grade glioma group, which was the primary endpoint, was lower than in the control group and that the predefined criteria for success were not achieved. The primary cause may be due to bias in the poor prognostic factors. In terms of the safety evaluation, the administration of a single intravenous dose of NMK36 was considered to be acceptable for clinical use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 49
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.
-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.
-Patients who received or are to receive 11C-MET-PET during trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy: comparison of Progression Free Survival rate during 9months in patients with clinically- suspected high-grade glioma between groups<br>Safety: subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy: comparison of Progression Free Survival rate during 6months, comparison of Progression Free Survival rate during 9months other than suspected high-grade glioma, comparison of Progression-Free Survival periods, the rate that NMK36-PET contributes to decide or changes the area of tumor-resection, positive-predictive value of PET imaging in the regions which are not visualized clearly by contrast T1-weighted MRI, 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, 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