Open-label study to assess efficacy (diagnostic performance) 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-jRCT2080222934
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
Efficacy evaluations verified that NMK36 depict tumors present in areas that are not contrast-enhanced on MRI images with a high PPV in patients with high- and low-grade glioma. We believe that NMK36 accumulation sites are useful for showing areas that are highly likely to be tumor areas in suspected high-grade glioma and suspected low-grade glioma patients. Moreover, the results of safety assessments indicate that single intravenous administration of NMK36 can be tolerated in clinical use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 22
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.
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 clearly 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: 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