UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039200 |
|---|---|
| Receipt number | R000044705 |
| Scientific Title | Multicenter prospective study of dedicated breast positron emission tomography for breast cancer |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2024/01/24 14:39:20 |
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Basic information
Public title
Multicenter prospective study of dedicated breast positron emission tomography for breast cancer
Acronym
Multicenter prospective study of dedicated breast positron emission tomography for breast cancer
Scientific Title
Multicenter prospective study of dedicated breast positron emission tomography for breast cancer
Scientific Title:Acronym
Multicenter prospective study of dedicated breast positron emission tomography for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find out which patient group and clinical condition are more useful in dbPET imaging method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breast cancer detection rate
Key secondary outcomes
To assess dbPET images and patient background
To assess dbPET images and other imaging methods
To assess dbPET images and histological findings
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
Patients who can agree to participate in this study of their own will, and have given consent in writing, and aged 20 years and older at the time of informed consent.
Key exclusion criteria
Patients who cannot maintain rest in the position. abdominal position
Patients who are pregnancy or suspicion of pregnancy at the time of dbPET inspection.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nagano |
| Middle name | |
| Last name | Hiroaki |
Organization
Yamaguchi university graduate school of medicine
Division name
Department of Gastorenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL
0836222264
geka2dm@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Maeda |
Organization
Yamaguchi university
Division name
Department of Gastroenterological, Breast and Endcrine Surgery
Zip code
7558505
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL
0836222264
Homepage URL
geka2dm@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
Tel
0836222428
clin_res@yamaguchi-u.ac.jp
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
| 2020 | Year | 01 | Month | 20 | 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
| 2019 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To find out which patient group and clinical condition are more useful in dbPET imaging method.
Management information
Registered date
| 2020 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044705
