UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036540 |
|---|---|
| Receipt number | R000041633 |
| Scientific Title | A validation study of efficacy of image fusion technique using magnetic position tracking system (Real-time virtual sonography or Volume navigation) for the localization of breast cancer with non-mass enhancement in breast conserving surgery (prospective multicenter study) : FUSION 02 study |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/10/20 18:15:37 |
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Basic information
Public title
A validation study of efficacy of image fusion technique using magnetic position tracking system (Real-time virtual sonography or Volume navigation) for the localization of breast cancer with non-mass enhancement in breast conserving surgery (prospective multicenter study) : FUSION 02 study
Acronym
FUSION 02 study
Scientific Title
A validation study of efficacy of image fusion technique using magnetic position tracking system (Real-time virtual sonography or Volume navigation) for the localization of breast cancer with non-mass enhancement in breast conserving surgery (prospective multicenter study) : FUSION 02 study
Scientific Title:Acronym
FUSION 02 study
Region
| Japan |
Condition
Condition
Breast cancer with non-mass enhancement (NME) detected by MRI
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether Real-time virtual sonography (RVS)/Volume navigation (Vnav) contribute to the improvement of margin positive rate of breast cancer with NME in breast conserving surgery by prospective multicenter cohort study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of margin positive after pre-operative marking using RVS/Vnav in breast conserving surgery for breast cancer with NME
Key secondary outcomes
1) The detection rate of NME in supine MRI
2) The required time to detect the border of the area of NME by using RVS/Vnav
3) The required time to put the breast tissue marker at the border of the area NME
4) The detection rate of the breast tissue marker by the pre-operative ultrasound
5) Operation time and weight of resected specimen in breast conserving surgery,
6) Distance between breast tissue marker and pathological surgical margin
7) The re-operation rate and re-operation operative method
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Fusion imaging technique using Ultrasound ( RVS / Vnav )
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) A patient who has a breast cancer with NME in breast MRI examination
2) Female aged over 20 years old
3) Performance status 0, 1
4) Agreement on informed consent for this clinical trial
Key exclusion criteria
1) A patient with a pacemaker
2) A patient with allergy for a contrast medium for MRI
3) A patient with a metallic artificial heart valve
4) A patient with past asthmatic symptom
5) A patient with a severe renal dysfunction
6) A patient with a severe claustrophobia
7) A patient with a tattoo
8) A patient who is not able to perform breast MRI with some reasons.
9) A patient who is pregnant or a patient who has a possibility of being pregnant
10) A patient who is lactating
11) A patient who is not able to perform breast conserving surgery
12) A patient who has a history of mental disorder or central nervous disorder
13) A patient who was received neoadjuvant chemotherapy.
14) A patient with allergy for a titanium
15) A patient with allergy for a xylocaine
16) A patient who is not considered suitable by doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Nakano |
Organization
Aichi Medical University
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagate-city, Aichi, Japan
TEL
0561-62-3311
snakano1@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Nakano |
Organization
Aichi Medical University
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagate-city, Aichi, Japan
TEL
0561-62-3311
Homepage URL
snakano1@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazakokarimata, Nagate-city, Aichi, Japan
Tel
0561-62-3311
snakano1@aichi-med-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
愛知医科大学病院（愛知県）、大垣市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 18 | Day |
Last modified on
| 2020 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041633
