UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003338 |
|---|---|
| Receipt number | 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 15:42:07 |
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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
| Obstetrics 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
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
yamane@fbri.org
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003985
