UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007872 |
|---|---|
| Receipt number | R000009091 |
| Scientific Title | The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant central nervous system tumor. |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2012/05/01 18:26:22 |
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Basic information
Public title
The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant central nervous system tumor.
Acronym
Five-aminolevulinic acid for fluorescence-guided resection of malignant brain tumor.
Scientific Title
The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant central nervous system tumor.
Scientific Title:Acronym
Five-aminolevulinic acid for fluorescence-guided resection of malignant brain tumor.
Region
| Japan |
Condition
Condition
malignant tumor of central nervous system
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study assess the feasibility of intraoperative 5-aminolevulinic acid (5-ALA) fluorescence guidance for resection of malignant brain tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resection rate
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
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 bellow are included.
1. Patients who are hospitalized at Kobe university hospital in order to undergo surgery.
2. Patients who are diagnosed with malignant tumor of CNS preoperatively.
3. Patients who provide a wittern informed consent.
Key exclusion criteria
Patients who meet any of the conditions described bellow are excluded.
1) Patients with porphyria
2) Patients with hypersensitivity to 5-ALA or porphyrins
3) In case of renal insufficiency (serum creatinine is more than 2.0 mg/dL)
4) In case of hepatic insufficiency
(total bilirubin >3 mg/dL, gamma-GTP >100 U/L, ptptprombin time <60%)
5) In case of known or suspected pregnancy,or woman who are breast-feeding.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sasayama |
Organization
Kobe university hospital
Division name
Neurosurgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe university hospital
Division name
Neurosurgery
Zip code
Address
TEL
078-382-5966
Homepage URL
Sponsor or person
Institute
Department of Neurosurgery, Kobe 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009091
