UMIN-CTR Clinical Trial

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
Email	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
Email	tanakas-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Faculty of Medicine Department of Neurosurgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020798