UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012547 |
|---|---|
| Receipt number | R000014036 |
| Scientific Title | Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion |
| Date of disclosure of the study information | 2013/12/12 |
| Last modified on | 2020/01/30 19:22:38 |
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Basic information
Public title
Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion
Acronym
Efficacy and safety of MRI guided vacuum assisted biopsy
Scientific Title
Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion
Scientific Title:Acronym
Efficacy and safety of MRI guided vacuum assisted biopsy
Region
| Japan |
Condition
Condition
MRI only visible lesion
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible breast lesion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of breast cancer.
Key secondary outcomes
Hazardous phenomenon
Negative productive value
success rate of procedure
Pathological type
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
All patients are performed MRI guided vacuum assisted biopsy for MRI only visible breast lesion.
After the patient receives skin anesthesia, the needle path is cut by a precutter according to these coordinates. After the patient receives additional deep local anesthesia, VAB is performed outside the magnet, and specimens are acquired. After VAB is finished, the breast is reimaged before and after another contrast injection to check whether the intervention was successful.
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
1) 1:malignancy is highly suspected lesion (over category 4 BIRADS-MRI)
among MRI only visible lesions.
2:Biopsy is highly recommended lesion (over category 3 BIRADS-MRI)among MRI only visible lesions of which those have BRCA1 /2 mutation
2) Over twenty yeares-old.
3) Performance status is 0 to2.
4) An informed conscent was obtained from all patients after they had been provided with a detailed explanation about the procedure.
Key exclusion criteria
1)History of allergy for contrast medium (Gd-DTPA)
2) The lesion is too close to perform the procedure.
3) Serious heart disease or arrithmia.
4) Serious liver dysfunction
5) Serious renal dysfunction
6) During anti-coagulation therapy
7) MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
8) During or possible of pregnancy
9) Staff decides inadequate case for current study
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University Hospital
Division name
Breast Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5869
morihito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kajitani |
Organization
Hiroshima University Hospital
Division name
Breast Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5869
Homepage URL
kajitanikeiko0226@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University Hospital
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5907
gaku-hiroshimajimu@office.hiroshima-u.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 12 | 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
5
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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 05 | 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 | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014036
