Open-label study to assess safety and efficacy of a single dose (i.v.) of NMK36 in subjects with brain tumor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221350

Enrollment

Registered

2011-01-14

Start date

2011-01-28

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

The subjects who were clinically-diagnosed with glioma

Interventions

investigational material(s) Generic name etc : fluciclovine(18F) INN of investigational material : fluciclovine(18F) Therapeutic category code : 43- Radioactive medicines Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -The subjects who were clinicaly-diagnosed with glioma and have been hospitalized for the surgical removal of the tumor. -The subjects showing enhanced effect clearly at the tumor involvement on Gd-MRI.

Exclusion criteria

Exclusion criteria: -The subjects who received treatment for glioma. -The subjects who are pregnant, lactating or possibly pregnant. -The subjects who have hepatic or renal dysfunction. -The subjects with Karnofsky performance status under 40%.

Design outcomes

Primary

Measure	Time frame
safety Safety: subjective/objective symptoms, electrocardiogram exam, vital signs, clinical tests efficacy Efficacy: visualization performance of PET for glioma, range of administered radioactivity, starting time for PET imaging	—

Secondary

Measure	Time frame
other None	—

Countries

Japan

Outcome results

None listed

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