UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009314 |
|---|---|
| Receipt number | R000010937 |
| Scientific Title | A prospective study to evaluate the effectiveness of positron emission mammography (PEM) in predicting the treatment outcome of chemotherapy in patients with breast cancer. |
| Date of disclosure of the study information | 2012/11/11 |
| Last modified on | 2012/11/11 19:42:15 |
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Basic information
Public title
A prospective study to evaluate the effectiveness of positron emission mammography (PEM) in predicting the treatment outcome of chemotherapy in patients with breast cancer.
Acronym
The evaluation of the effectiveness of PEM in breast cancer patients to predict the treatment outcome.
Scientific Title
A prospective study to evaluate the effectiveness of positron emission mammography (PEM) in predicting the treatment outcome of chemotherapy in patients with breast cancer.
Scientific Title:Acronym
The evaluation of the effectiveness of PEM in breast cancer patients to predict the treatment outcome.
Region
| Japan |
Condition
Condition
brast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of PEM to predict the treatment outcome of pre-operative chemotherapy and prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation of FDG uptake.
Key secondary outcomes
The correlation of FDG uptake with treatment outcome and prognosis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
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 PEM scan for the breast cancer patients to evaluate the FDG uptake of the tumor, and to analyse the correlation with treatment outcome and survival date.
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 with 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 | |
| Middle name | |
| Last name | Tomio Inoue |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Radiology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Shishikura |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Radiology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2696
Homepage URL
Sponsor or person
Institute
Department of Radiology, Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 11 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 11 | Day |
Last modified on
| 2012 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010937
