UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005617
Receipt number R000006629
Scientific Title Biological assessment for brain tumors in 5-ALA-induced fluorescence-guided surgery
Date of disclosure of the study information 2011/05/20
Last modified on 2018/11/22 09:36:19

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Basic information

Public title

Biological assessment for brain tumors in 5-ALA-induced fluorescence-guided surgery

Acronym

Fluorescence-guided surgery for brain tumors

Scientific Title

Biological assessment for brain tumors in 5-ALA-induced fluorescence-guided surgery

Scientific Title:Acronym

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

1st name
Middle name
Last name Naoya Hashimoto

Organization

Osaka University Hospital

Division name

Department of Neurosurgery

Zip code


Address

2-15, Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

0668793652

Email

hashimotonaoya@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Hideyuki Arita

Organization

Osaka University Hospital

Division name

Department of Neurosurgery

Zip code


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 or person

Institute

Department of Neurosrugery, Osaka University Hospital

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2011 Year 01 Month 13 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name