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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003338
Receipt No. R000003985
Scientific Title FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma: A prospective study
Date of disclosure of the study information 2010/03/15
Last modified on 2012/07/29

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Basic information
Public title FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma: A prospective study
Acronym FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma
Scientific Title FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma: A prospective study
Scientific Title:Acronym FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma
Region
Japan

Condition
Condition uterine smooth muscle tumor
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the utility of FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic ability of FLT-PET for differentiating between uterine leiomyosarcoma and leiomyoma
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 Device,equipment
Interventions/Control_1 FLT-PET, FDG-PET and MRI
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) Presence of uterine smooth muscle tumor confirmed by US, CT or MRI
2) Potentiality of uterine leiomyosarcoma
3) Without an experience of treatment for the tumor except for hormone therapy
4) Final diagnosis at 6 month after scan can be confirmed by the referring physician
Key exclusion criteria 1) Poor general condition
2) Poor control of diabetes mellitus
3) Pregnant or the possibility of pregnancy
4) Contraindication to MRI
5) Regarded ad unsuitable by responsible investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Senda
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Yamane
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Homepage URL
Email yamane@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 先端医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 15 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 Completed
Date of protocol fixation
2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 15 Day
Last modified on
2012 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003985

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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