Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in subjects with high / low- grade glioma.
- Conditions
- Patients who were clinically- suspected with high / low- grade glioma
- Registration Number
- JPRN-jRCT2080222240
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
The results of efficacy assessments showed that NMK36 visualized tumors present in regions of no contrast with MRI, in high-grade glioma patients and low-grade glioma patients. Since the PPV of NMK36 was 100% for both low-grade glioma patients and high-grade glioma patients, this suggests that it is useful for setting the extent of resection of gliomas. It is also considered that the results of safety assessments will enable single-dose intravenous administration of NMK36 to be permitted for clinical use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 42
Patients who were clinicaly-suspected with high / low- grade glioma by the clinical sign / course and MRI exam are to have the surgical removal of the tumor.
-Patients who received treatment for glioma.
-Patients who 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 40%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy: positive-predictive value of PET imaging in the regions which are not visualized by contrast T1-weighted MRI<br>Safety: subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy: range of administered radioactivity, range of starting time for PET imaging, search for semiquantitative index