UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002462 |
|---|---|
| Receipt number | R000002765 |
| Scientific Title | Evaluation of usefullness of 1H MR spectroscopy for diagnosis of breast tumors. |
| Date of disclosure of the study information | 2009/09/09 |
| Last modified on | 2014/09/07 09:26:59 |
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Basic information
Public title
Evaluation of usefullness of 1H MR spectroscopy for diagnosis of breast tumors.
Acronym
Usefullness of 1H MR spectroscopy of breast tumors
Scientific Title
Evaluation of usefullness of 1H MR spectroscopy for diagnosis of breast tumors.
Scientific Title:Acronym
Usefullness of 1H MR spectroscopy of breast tumors
Region
| Japan |
Condition
Condition
breast tumor
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefullness of 1H MR spectroscopy as malignancy marker of breast tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of density of choline compounds and tumor size before treatment
Key secondary outcomes
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
We will perform 1H MR spectroscopy to the patients of the breast cancer and measure the density of choline compounds which related to the composition and metabolism of the phospholipid of cell membrane. In addition, we will use the density of choline compounds as a marker for differential diagnosis of the breast cancer from benign tumors; phylodes tumor, papilloma and fibrocystic disease.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) The patient who is doubted having breast tumor in palpation, sonography, or mammography.
2) The patient who is seen a solid breast tumor more than 1.5cm in minor axis by post-contrasted MRI
3) The patient who signed a written informed consent form.
Key exclusion criteria
1) The patient who has any contraindication on MRI
2) The patient who cannot be taken contrast material of MRI.
3) The patient who has been taken biopsy of the breast tumor
4) The patient who ever has been taken surgery, chemotherapy, radiation or any other therapy for the breast tumor.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Waka Mizukoshi |
Organization
International medical center, Saitama medical university
Division name
Diagnostic Radiology
Zip code
Address
Yamane1397-1,Hidaka city, Saitama prefecture
TEL
042-984-4520
wsaito@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Waka Mizukoshi |
Organization
International medical center, Saitama medical university
Division name
Diagnostic Radiology
Zip code
Address
Yamane1397-1, Hidaka city, Saitama
TEL
042-984-4520
Homepage URL
wsaito@saitama-med.ac.jp
Sponsor or person
Institute
International medical center, Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
International medical center, Saitama medical 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
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
| 2009 | Year | 09 | 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
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2014 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002765
