UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030676 |
|---|---|
| Receipt number | 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 14:23:36 |
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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
| Obstetrics 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
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
r0149404@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035021
