UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014173 |
|---|---|
| Receipt number | R000016509 |
| Scientific Title | 18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2015/06/05 13:56:16 |
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Basic information
Public title
18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer
Acronym
18F-FMISO PET imaging in metastatic breast cancer
Scientific Title
18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer
Scientific Title:Acronym
18F-FMISO PET imaging in metastatic breast cancer
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate tumor hypoxia and efficacy of eribulin using 18F-FMISO PET in metastatic breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUV level of FMISO PET and the change after treatment of eribulin
Key secondary outcomes
Base
Study type
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 |
Interventions/Control_1
18F-FMISO 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients over 20y.o. with evaluatable lesion of metastatic breast cancer who were planned eribulin treatment
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Yamashita |
Organization
Hokkaido University Hospital
Division name
breast surgery
Zip code
Address
N14 W5 Kita-ku Sapporo city
TEL
011-706-7381
hosodam@seagreen.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuchika Hosoda |
Organization
Hokkaido University Hospital
Division name
breast surgery
Zip code
Address
N14 W5 Kita-ku Sapporo city
TEL
011-706-7381
Homepage URL
hosodam@seagreen.ocn.ne.jp
Sponsor or person
Institute
breast surgery Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
eizal inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | 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
| 2014 | Year | 06 | Month | 05 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016509
