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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030676
Receipt No. R000035021
Scientific Title The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Date of disclosure of the study information 2018/01/04
Last modified on 2019/03/05

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Basic information
Public title The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Acronym The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Scientific Title The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Scientific Title:Acronym The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Region
Japan

Condition
Condition Endometriosis
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The diagnosis of the endometriosis is generally made by laparoscope, but it is invasive.Endometriosis and its localization is diagnosed clinically, and treatment is often provided without getting a pathological diagnosis.Noninvasive diagnostic imaging with accuracy equal to or greater than laparoscope is expected.
Sympathetic fiber develops in endometriotic lesion.Localization of the endometriosis could be diagnosed with I-123 MIBG noninvasively.
The purpose of this study is to consider the clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion.


Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the operation results and I-123 MIBG SPECT/MRI fusion image results of the endometriosis and to calculate sensitivity and specificity.
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 Iodine I 123 metaiodobenzylguanidine 111 MBq i.v.
Administration period:One day,1 time
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 Female
Key inclusion criteria Patient who gives written informed consent before enrolling the study.
Key exclusion criteria Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Kan
Organization Kansai Medical University Hospital
Division name Department of Radiology
Zip code
Address Oosakahu hirakatashi sinmati 2-3-1
TEL 072-804-0101
Email r0149404@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Kan
Organization Kansai Medical University Medical Center
Division name Department of Radiology
Zip code
Address Oosakahu morigutishi humizonotyo 10-15
TEL 06-6992-1001
Homepage URL
Email r0149404@gmail.com

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) FUJIFILM RI Pharma Co., Ltd.

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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2017 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 Day
Last follow-up date
2018 Year 11 Month 10 Day
Date of closure to data entry
2019 Year 03 Month 05 Day
Date trial data considered complete
2019 Year 03 Month 05 Day
Date analysis concluded
2019 Year 03 Month 05 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 04 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035021

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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