UMIN-CTR Clinical Trial

Basic information
Public title	Intraoperative neurophysiology for stereotactic biopsy of the brain/brainstem tumor
Acronym	Stereotactic biopsy of the brain/brainstem tumor
Scientific Title	Intraoperative neurophysiology for stereotactic biopsy of the brain/brainstem tumor
Scientific Title:Acronym	Stereotactic biopsy of the brain/brainstem tumor
Region	Japan

Condition
Condition	Brain/brainstem tumors
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To perform stereotactic biopsy of the brain/brainstem tumor safely under intraoperative neurophysiological procedure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety of the stereotactic biopsy surgery Newly developed neurological deficit within 24 hours after the surgery is evaluated.
Key secondary outcomes	Functional localization of the brain/brainstem structures

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	Maneuver
Interventions/Control_1	During the stereotactic surgery, critical neural structures (corticospinal/corticobulbar tracts, cranial motor/sensory nuclei, and others) are mapped/localized by electrical stimulation through the surgical tract.
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	Brain/brainstem tumors subjected for the stereotactic biopsy surgery
Key exclusion criteria	Open cranial surgery Patients with hemorrhagic tendency
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhito Morota
Organization	Kitasato University School of Medicine
Division name	Department of Neurosurgery
Zip code
Address	1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	nobu.m01@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Nobuhito Morota
Organization	Kitasato University School of Medicine
Division name	Department of Neurosurgery
Zip code
Address	1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	nobuhito_morota@tmhp.jp

Sponsor
Institute	Department of Neurosurgery Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	None
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
Email

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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 31 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	0
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	Terminated
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 07 Month 08 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2019 Year 07 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 06 Day
Last modified on	2020 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041137