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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005029
Receipt No. 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

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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
Email

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
Email sakashi@ncc.go.jp

Sponsor
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

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
Email

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
URL(English) https://upload.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


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