UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023607 |
|---|---|
| Receipt number | 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 | 2020/08/15 09:20:49 |
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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
| Obstetrics 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
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
kmurakami@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027181
