UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030883 |
|---|---|
| Receipt number | R000035260 |
| Scientific Title | Photodynamic Therapy (PDT) for malignant brain tumor in children. |
| Date of disclosure of the study information | 2018/01/28 |
| Last modified on | 2018/01/18 20:54:24 |
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Basic information
Public title
Photodynamic Therapy (PDT) for malignant brain tumor in children.
Acronym
Photodynamic Therapy (PDT) for malignant brain tumor in children.
Scientific Title
Photodynamic Therapy (PDT) for malignant brain tumor in children.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kawamata Takakazu |
Organization
Tokyo Women's Medical University
Division name
The department of neurosurgery
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
tkawamata@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiba Kentaro |
Organization
Tokyo Women's Medical University
Division name
The department of neurosurgery
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
chibak920@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035260
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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