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
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
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
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
