UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023246 |
|---|---|
| Receipt number | R000026789 |
| Scientific Title | Intraoperative Photodynamic Diagnosis study by fluorescent labeling with 5-aminolevulinic acid in Endocrine Surgery |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/20 14:50:01 |
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Basic information
Public title
Intraoperative Photodynamic Diagnosis study by fluorescent labeling with 5-aminolevulinic acid in Endocrine Surgery
Acronym
IPDES
Scientific Title
Intraoperative Photodynamic Diagnosis study by fluorescent labeling with 5-aminolevulinic acid in Endocrine Surgery
Scientific Title:Acronym
IPDES
Region
| Japan |
Condition
Condition
Thyroid, parathyroid and adrenal diseases
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to identify the red florescent light of endocrine tumor (thyroid, parathyroid and adrenal) by administering 5-aminolevulinic acid preoperatively using blue and white light and compare histopathology of normal and tumor tissue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify the parathyroid gland or adrenal medulla intraoperatively.
To evaluate if there is no severe organ dysfunction by administering 5-ALA.
Key secondary outcomes
To evaluate the parathyroid gland or the adrenal cortex gland are not detected in histopathology of surgically removed specimen.
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
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Administering 5ALA method
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are sufficiently explained and agreed with this experiment by written documents.
Female or male above 20 years old.
Key exclusion criteria
Patients who are contraindication to aminolevulinic acid.
Patients who have cardiovascular disease, liver dysfunction or kidney disease.
Patients who are under 20 years old, expectant or nursing mothers are excluded.
Patients who take medication or food associated with the risk for the onset of photo-hypersensitivity with 5-ALA.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ritsuko Okamura |
Organization
Nippon Medical School
Division name
Endocrine Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-5814-6219
ritsuokamura@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ritsuko Okamura |
Organization
Nippon Medical School
Division name
Endocrine Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-5814-6219
Homepage URL
ritsuokamura@gmail.com
Sponsor or person
Institute
Endocrine surgery, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
日本医科大学付属病院（東京都）／Nippon Medical School Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | 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
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026789
