UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005029 |
|---|---|
| Receipt number | R000005941 |
| Scientific Title | Evaluation of the usefulness of breast CT imaging in delineating tumor extent and guiding surgical management: a prospective multi-institutional study |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2011/02/04 08:56:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the usefulness of breast CT imaging in delineating tumor extent and guiding surgical management: a prospective multi-institutional study
Acronym
Evaluation of the usefulness of breast CT imaging in delineating tumor extent and guiding surgical management: a prospective multi-institutional study
Scientific Title
Evaluation of the usefulness of breast CT imaging in delineating tumor extent and guiding surgical management: a prospective multi-institutional study
Scientific Title:Acronym
Evaluation of the usefulness of breast CT imaging in delineating tumor extent and guiding surgical management: a prospective multi-institutional study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the usefulness of CT imaging in addition to mammography, ultrasonography and palpation, in delineating tumor extent and guiding surgical management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate at which CT findings modified the planned surgical procedure, and whether or not it was effective.
1) If the newly identified region by CT included tumor in the pathological examination, the alteration was judged as effective.
2) If pathological examination revealed no tumor in the newly identified region, the alteration was evaluated as ineffective.
Key secondary outcomes
false negative detection
false positive detection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
performing breast CT preoperatively
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) Patients with histologically proven breast cancer, who were candidates for BCS as determined by palpation, MMG and US.
2) Patients without microcalcifications or with microcalcifications at most 2 cm away from the tumor).
3) Patients who provided written informed consent.
Key exclusion criteria
1) Patients who have allergy to iodine containing contrast medium.
2) Patients who received neoadjuvant chemotherapy or endocrine therapy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Futoshi Akiyama |
Organization
Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan
Division name
Division of Pathology
Zip code
Address
Ariake 3-8-31 Koto-ku, Tokyo
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadako Akashi-Tanaka |
Organization
National Cancer Center Hospital, Tokyo, Japan
Division name
Breast Surgery Division
Zip code
Address
Tsukiji 5-1-1 Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
sakashi@ncc.go.jp
Sponsor or person
Institute
Grants for Scientific Research from the Expenses for Health and Welfare Program (17-7) from the Ministry of Health, Labour and Welfare of Japan
Institute
Department
Personal name
Funding Source
Organization
Grants for Scientific Research from the Expenses for Health and Welfare Program (17-7) from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立がん研究センター病院（東京）、新潟県立がんセンター新潟病院（新潟県）、四国がんセンター（愛媛県）、大阪成人病センター（大阪府）、北福島医療センター（福島県）、呉医療センター中国がんセンター（広島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2005 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 05 | Day |
Last modified on
| 2011 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
