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Recruitment status
Unique ID issued by UMIN UMIN000023246
Receipt No. 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

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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
Email 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
Email ritsuokamura@gmail.com

Sponsor
Institute Endocrine surgery, Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026789

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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