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

Phase 2

Completed

• Conditions: The subjects who were clinically-diagnosed with glioma

• Registration Number: JPRN-jRCT2080221350
• Lead Sponsor: ihon Medi-Physics Co., Ltd.

Brief Summary

The safety results show that clinical use can be tolerated; the efficacy results show that NMK36 PET scans afford good glioma delineation ability, and suggest that NMK36 PET scans can delineate the presence and spread of tumour that cannot be diagnosed by contrast MRI. The results also show that good delineation ability of tumour can be achieved using 87-270 MBq with a PET scan start time of from immediately after to 60 min after NMK36 administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-14
• Study Completion: 2012-03-14
• Results First Posted: 2016-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 6

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

-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%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified