UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007347 |
|---|---|
| Receipt number | R000008660 |
| Scientific Title | Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST). |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2012/12/25 19:20:01 |
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Basic information
Public title
Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST).
Acronym
Feasibility study of dbPET
Scientific Title
Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST).
Scientific Title:Acronym
Feasibility study of dbPET
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the images obtained by dbPET, not whole body PET, in PST
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FDG PET images on dbPET scan after the first cycle of PST.
Key secondary outcomes
Comparison between db PET and MRI or pathologic findings of resected specimen
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
| Device,equipment |
Interventions/Control_1
db 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
1. Female patients with primary breast cancer diagnosed by palpation, imagings and cytology, with T stage >=T1and M0.
2.The patinets should be scheduled to receive PST.
3.Female patients who can agree to participate in this study of their own will, and aged 20 years and older at the time of informed consent.
Key exclusion criteria
1. Patients with sever impairement in communications.
2. Patients with very poor general conditions (such as abnormal vital signs).
3. Patients who are pregnancy or suspicion of pregnancy.
4. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Toi |
Organization
Graduate School of Medicine Kyoto University
Division name
Breast Surgery
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoharu Sugie |
Organization
Graduate School of Medicine Kyoto University
Division name
Breast Surgery
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
sugie@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Shimazu Co.
Name of secondary funder(s)
Shimazu Co.
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 08 | 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
| 2012 | Year | 02 | Month | 21 | Day |
Last modified on
| 2012 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008660
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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