UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017946 |
|---|---|
| Receipt number | R000020798 |
| Scientific Title | Intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid and purple-color light emitting diode |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2021/06/21 09:32:36 |
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Basic information
Public title
Intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid and purple-color light emitting diode
Acronym
Intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid
Scientific Title
Intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid and purple-color light emitting diode
Scientific Title:Acronym
Intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid
Region
| Japan |
Condition
Condition
Brain tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of intraoperative fluorescence staining of brain tumors using 5-aminolevulinic acid (5-ALA) and purple-color light emiting diode
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Safety
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 5-aminolevulinic acid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgical biopsy or resection for suspected malignant brain tumor based on preoperative imaging, including brain metastasis, malignant lymphoma, medulloblastoma, and germ cell tumor
Key exclusion criteria
Patients with suspected glioma: Alabel (5-aminolevulinic acid) is covered by insurance
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
TEL
03-5800-8853
nsaito-tky@umin.net
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
TEL
03-5800-8853
Homepage URL
http://www.h.u-tokyo.ac.jp/neurosurg/rinsho/noushu.htm
tanakas-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Faculty of Medicine
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
東京大学医学部附属病院（東京都）
The University of Tokyo Hospital (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
45
Results
Currently being analyzed
Results date posted
| 2021 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Malignant brain tumors excluding gliomas
Participant flow
1. oral intake of 5-ALA before surgery
2. neurosurgery
3. tumor resection using fluorescence
4. light avoidance after surgery
Adverse events
None
Outcome measures
Currently being analyzed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020798
