UMIN-CTR Clinical Trial

Basic information
Public title	Superparamagnetic iron oxide (SPIO) enhanced MRI for the detection of lymph node metastasis of uterine cervical and endometrial cancer
Acronym	Superparamagnetic iron oxide (SPIO) enhanced MRI for the detection of lymph node metastasis of uterine cervical and endometrial cancer
Scientific Title	Superparamagnetic iron oxide (SPIO) enhanced MRI for the detection of lymph node metastasis of uterine cervical and endometrial cancer
Scientific Title:Acronym	Superparamagnetic iron oxide (SPIO) enhanced MRI for the detection of lymph node metastasis of uterine cervical and endometrial cancer
Region	Japan

Condition
Condition	uterine cervical cancer uterine endometrial cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of SPIO-enhanced MRI for lymph node metastasis of uterine cervical and endometrial cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of lymph node metastasis
Key secondary outcomes	safety of administration of SPIO

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 Device,equipment Maneuver
Interventions/Control_1	SPIO (Ferucabotran) is administered by intravenous or local injection, and MRI is performed after a few hours.
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	1.Case of cervical or endometrial cancer planned lymph node dissection 2.Case which is obtained agreement of participation in this study
Key exclusion criteria	1.pregnancy 2.metal placement or claustrophobia 3.allergy of iron or SPIO
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Noriomi Middle name Last name Matsumura
Organization	Kindai University Faculty of Medicine
Division name	Department of Obstetrics & Gynecology
Zip code	589-8511
Address	377-2,Ono-higashi,Osaka-sayama,Osaka,Japan
TEL	072-366-0221
Email	mandai@med.kindai.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Murakami
Organization	Kindai University Faculty of Medicine
Division name	Department of Obstetrics & Gynecology
Zip code	589-8511
Address	377-2,Ono-higashi,Osaka-sayama,Osaka,Japan
TEL	072-366-0221
Homepage URL
Email	kmurakami@med.kindai.ac.jp

Sponsor
Institute	Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University Faculty of Medicine
Address	377-2,Ono-higashi,Osaka-sayama,Osaka,Japan
Tel	072-366-0221
Email	zizen@med.kindai.ac.jp

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	2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	15
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	2015 Year 07 Month 01 Day
Date of IRB	2015 Year 10 Month 09 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 12 Day
Last modified on	2020 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027181