An open-label study of photodynamic therapy with ME2906 and PNL6405CNS in patients with malignant brain tumor

Phase 2

Completed

• Conditions: Malignant brain tumor

• Registration Number: JPRN-jRCT1091220026
• Lead Sponsor: Faculty of Advanced Techno-Surgery,Institute of Advanced Biomedical Engineering and Science,Tokyo Women's Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-19
• Study Completion: 2012-09-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1)Preoperative diagnostic imaging reveals the possibility of a primary malignant brain tumor
2)Patients suitable for tumor resection
3)Pretreatment MRI revealing that 50% or more of tumor mass is in supratentorial region
4)Pretreatment MRI revealing no tumor on optic nerve, olfactory nerve or pituitary gland
5)Pretreatment MRI revealing no dissemination
6)Patients themselves providing written consent to participation in the study
etc.

Exclusion Criteria

1)Severe cardiovascular, blood, hepatic, gastrointestinal, renal, respiratory, endocrine, neurologic or psychiatric disorder
2)Serious bleeding or shock
3)Prone to bleeding
4)Serious infection
5)Pregnant or possibly pregnant women, or lactating women
6)Other patients judged by investigator or sub-investigator as inappropriate for the study
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, Response rate, etc.