UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026181 |
|---|---|
| Receipt number | R000029947 |
| Scientific Title | Detectability of malignant breast tumor by portable breast tumor detector |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2019/01/23 21:25:18 |
* 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
Detectability of malignant breast tumor by portable breast tumor detector
Acronym
PORBRATOR study
Scientific Title
Detectability of malignant breast tumor by portable breast tumor detector
Scientific Title:Acronym
PORBRATOR study
Region
| Japan |
Condition
Condition
Mlignant breast tumor
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability to detect breast tumors by portable breast tumor detection device in patients with malignant breast tumor with a maximum diameter of 1 cm or more.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of malignant breast tumor
Key secondary outcomes
Accuracy of breast tumor position
Adverse event
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
Measurement by portable breast tumor detector
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. Female older than 20 years old.
2. Patients with histologically confirmed malignant breast tumor.
3. Maximum tumor size is 1 cm or more by two or more arbitrary image examination; mammography, breast ultrasonography, contrast breast MRI and FDG-PET examination.
4. Signed informed consent
Key exclusion criteria
1. History of chemotherapy or radiotherapy.
2. Hypersensitivity to ABS plastic resin.
3. Having a pacemaker.
4. Decision of the physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihito Okada |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name
Surgical Oncology
Zip code
Address
1-2-3 Kasumi, Minami-Ku, Hiroshima City, Hiroshima 734-8551, Japan
TEL
082-257-5869
morihito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Sasada |
Organization
Hiroshima University Hospital
Division name
Breast Surgery
Zip code
Address
1-2-3 Kasumi, Minami-Ku, Hiroshima City, Hiroshima 734-8551, Japan
TEL
082-257-5555
Homepage URL
shsasada@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spiedigitallibrary.org/journals/journal-of-medical-imaging/volume-5/issue-02
Number of participants that the trial has enrolled
Results
Detection rate: 100%
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
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 30 | Day |
Other
Other related information
1. http://www.nature.com/articles/s41598-017-16617-6
2. https://www.spiedigitallibrary.org/journals/Journal-of-Medical-Imaging/volume-5/issue-2/025502/Portable-impulse-radar-detector-for-breast-cancer--a-pilot/10.1117/1.JMI.5.2.025502.short?SSO=1
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029947
