UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical efficacy of endometriosis diagnosis using I-123 MIBG SPECT and MRI image fusion
Title of the study (Brief title)	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	Naoki Kan
Organization	Kansai Medical University Hospital
Division name	Department of Radiology
Address	Oosakahu hirakatashi sinmati 2-3-1
TEL	072-804-0101
Email	r0149404@gmail.com

Public contact
Name of contact person	Naoki Kan
Organization	Kansai Medical University Medical Center
Division name	Department of Radiology
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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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