UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016488 |
|---|---|
| Receipt number | R000013095 |
| Scientific Title | Examination of Clinical usefulness of FES-PET for hormone therapy against recurrence after adjuvant hormone therapy of estrogen receptor-positive breast cancer |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2016/02/09 09:36:21 |
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Basic information
Public title
Examination of Clinical usefulness of FES-PET for hormone therapy against recurrence after adjuvant hormone therapy of estrogen receptor-positive breast cancer
Acronym
FES-1
Scientific Title
Examination of Clinical usefulness of FES-PET for hormone therapy against recurrence after adjuvant hormone therapy of estrogen receptor-positive breast cancer
Scientific Title:Acronym
FES-1
Region
| Japan |
Condition
Condition
Recurrence of estrogen-positive breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of sensitivity and therapeutic effect of hormonal agents for patients with recurrence lesion after adjuvant hormonal therapy of estrogen receptor-positive breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FES accumulation change of recurrence lesion
FDG accumulation change of recurrence lesion
FES and FDG accumulation region of recurrence lesion
Change of size and form of recurrence lesion
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
FES-PET,FDG-PET
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Postmenopausal women
Good general condition (PS 1 or 2)
Subject who is diagnosed with recurrence after adjuvant hormone therapy against estrogen receptor-positive breast cancer
Key exclusion criteria
Subject who can not be maintained for 60 minutes on her back
Subject who is claustrophobic extremely
Subject with poor blood sugar control ( blood glucose kevel is more then 200mg/dl on the examination day)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Senda |
Organization
Institusion of Biomedical Resarch and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2 Minatojima-Minamimachi,Cuo-ku Kobe, Hyogo
TEL
078-304-5212
senda@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Ohnishi |
Organization
Institusion of Biomedical Resarch and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima minamimachi, chuo-ku, Kobe, Hyogo
TEL
078-304-5212
Homepage URL
ohnishi@fbri.org
Sponsor or person
Institute
Institusion of Biomedical Resarch and Innovation
Institute
Department
Personal name
Funding Source
Organization
Institusion of Biomedical Resarch and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kobe City Medical Center General Hospital
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
| 2015 | Year | 02 | Month | 09 | 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
| 2013 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
