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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023607
Receipt No. R000027181
Scientific Title Superparamagnetic iron oxide (SPIO) enhanced MRI for the detection of lymph node metastasis of uterine cervical and endometrial cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2019/02/13

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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
Middle name
Last name Noriomi Matsumura
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
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
Middle name
Last name Kosuke Murakami
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
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
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
2017 Year 09 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 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 08 Month 12 Day
Last modified on
2019 Year 02 Month 13 Day


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

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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