UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Photodynamic Therapy (PDT) for malignant brain tumor in children.
Title of the study (Brief title)	Photodynamic Therapy (PDT) for malignant brain tumor in children.
Region	Japan

Condition
Condition	Malignant brain tumor in children
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Establishment of safety and adequate dose of Talaporfin sodium (Leserphyrin) as photosensitizer in cases of pediatric malignant brain tumor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	1. Safety (including photosensitivity test)(phase I) 2. Overall survival (OS) rate at 12 months after PDT (phase II)
Key secondary outcomes	1. Overall survival (OS) 2. Progression-free survival (PFS) rate at 6 months after PDT. 3. Progression-free survival 4. Safety (including photosensitivity test)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Medication: Talaporfin sodium (Leserphyrin) Dose: Dose-up from 10mg/square-20mg/square-40mg/square in sequence in every 3 cases since initial enrolled case. Finally, single drip intra-venous infusion of 40mg/square is required. Timing: 22-26 hours bafore surgical removal. Laser irradiation in a wave length of 664+/-2nm for tumor removal cavity 22-26 hours after drip intra-venous infusion of Talaporfin sodium.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients treated at the department of neurosurgery, Tokyo Women's Medical University, Tokyo, Japan(in both outpatient clinic and admission). 2. Man and woman, over the age of 6 years old and below the age of 20 years old at enrollment. 3. In an initial case, patients who are highly suspicious for primary malignant brain tumor from pre-operative neuro-imaging. In a recurrent case, patient who is diagnosed as primary malignant brain tumor at previous histopathological diagnosis.
Key exclusion criteria	1. Patients without surgical tumor removal. 2. Unusable for Talaporfin Sodium. 3. Non intended histopathological types of brain tumor. 4. Patients necessary for VEP monitoring. 5. Pregnancy or possibility of pregnancy. 6. Patients who are expected poor compliance with light shielding protection. 7. Patients regarded as ineligible by principal investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Kawamata Takakazu
Organization	Tokyo Women's Medical University
Division name	The department of neurosurgery
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	tkawamata@twmu.ac.jp

Public contact
Name of contact person	Chiba Kentaro
Organization	Tokyo Women's Medical University
Division name	The department of neurosurgery
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	chibak920@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University, the department of neurosurgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 18 Day
Last modified on	2018 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035260