Skip to content

Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in subjects with high / low- grade glioma.

Open-label study to assess efficacy and safety of a single dose (i.v.) of NMK36 in subjects with high / low- grade glioma.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222240
Enrollment
35
Registered
2013-10-01
Start date
2013-10-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who were clinically- suspected with high / low- grade glioma

Interventions

185 MBq/2 mL when calibrated) was administered intravenously into, for example, the arm, then flushed with physiological saline. The radiation dosages administered were regulated by the time of admini

Sponsors

Nihon Medi-Physics Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: -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%.

Design outcomes

Primary

MeasureTime frame
safety efficacy Efficacy: positive-predictive value of PET imaging in the regions which are not visualized by contrast T1-weighted MRI Safety: subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests

Secondary

MeasureTime frame
efficacy Efficacy: range of administered radioactivity, range of starting time for PET imaging, search for semiquantitative index

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026