UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012517 |
|---|---|
| Receipt number | R000014651 |
| Scientific Title | A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2019/03/31 11:55:10 |
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Basic information
Public title
A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer
Acronym
To evaluate the effectiveness of dbPET in patients undergoing neoadjuvant chemotherapy for breast cancer
Scientific Title
A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer
Scientific Title:Acronym
To evaluate the effectiveness of dbPET in patients undergoing neoadjuvant chemotherapy for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic ability of dedicated breast positron emission tomography (dbPET) can do predict the outcome of pathological results of the patients undergoing neoadjuvant chemotherapy for breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with the pathological findings
Key secondary outcomes
Comparison with MRI diagnosis
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
Perform dbPET scan for patients undergoing neoadjuvant chemotherapy for breast cancer, and to analyze the correlation between the FDG uptake of the lesions and pathological diagnosis or the MRI diagnosis.
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
The patients undergoing neoadjuvant chemotherapy for breast cancer
Key exclusion criteria
1.Pregnant and possibly pregnant women
2.Other patients determined to be inappropriate by physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadatoshi |
| Middle name | |
| Last name | Sugae |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of gastroterological surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2650
sugae@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sadatoshi |
| Middle name | |
| Last name | Sugae Sadatoshi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of gastroterological surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2650
Homepage URL
sugae@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Department of gastroterological surgery, Graduate School of Medicine, Yokohama City 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
Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
Tel
045-787-2650
sugae@yokohama-cu.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
| 2013 | Year | 12 | 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
15
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 | 07 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014651
