UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biological assessment for brain tumors in 5-ALA-induced fluorescence-guided surgery
Title of the study (Brief title)	Fluorescence-guided surgery for brain tumors
Region	Japan

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

Objectives
Narrative objectives1	This report analyzed relationships among histology, radiological findings, and 5-ALA-induced fluorescence, using surgical specimens obtained with navigation-guided stereotactic biopsy. The present study aimed to reveal the tumor characteristics relating with 5-ALA-induced fluorescence, in order to refine glioma resection using these techniques.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histological findings of surgical specimens and 5-ALA induced fluorescence
Key secondary outcomes

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-ALA
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 who meet all of the requirements described below are includesd. 1. Patients who are hospitalized in order to undergo surgery. 2. Patients whose preoperative diagnosis is glioma, meningioma or metastatic brain tumor. 3. Patients who provide a written informed consent.
Key exclusion criteria	Patients who meet any of the conditions described below are excluded. 1. Patients with hypersensitivity to 5-ALA or porphyrins. 2. In case of known or suspected pregnancy, or women who are breast-feeding. 3.In case of known or suspected acute or chronic types of porphyria. 4. In case of renal insufficiency (serum creatinine is more than 2.0mg/dl) 5. In case of hepatic insufficiency (serum gamma glutamyl transpeptidase >100IU/l, ptotronbin time <60% or total bilirubin >3mg/dl) 6. In case of other conditions considered as undesirable for entry in this clinical trial.
Target sample size	75

Research contact person
Name of lead principal investigator	Naoya Hashimoto
Organization	Osaka University Hospital
Division name	Department of Neurosurgery
Address	2-15, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	0668793652
Email	hashimotonaoya@me.com

Public contact
Name of contact person	Hideyuki Arita
Organization	Osaka University Hospital
Division name	Department of Neurosurgery
Address	2-15, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-5111
Homepage URL
Email	h-arita@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Neurosrugery, Osaka University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	大阪大学医学部付属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 13 Day
Anticipated trial start date	2011 Year 01 Month 13 Day
Last follow-up date	2013 Year 09 Month 01 Day
Date of closure to data entry	2013 Year 09 Month 01 Day
Date trial data considered complete	2013 Year 09 Month 01 Day
Date analysis concluded	2013 Year 09 Month 01 Day

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

Management information
Registered date	2011 Year 05 Month 18 Day
Last modified on	2018 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006629