UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023614 |
|---|---|
| Receipt number | R000027192 |
| Scientific Title | Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer |
| Date of disclosure of the study information | 2016/08/13 |
| Last modified on | 2016/08/13 10:34:17 |
* 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
Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer
Acronym
Detection of micro-metastasis of lymph node in patients with breast cancer
Scientific Title
Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer
Scientific Title:Acronym
Detection of micro-metastasis of lymph node in patients with breast cancer
Region
| Japan |
Condition
Condition
Patients who will diagnosed with breast cancer, and will be performed radical breast surgery without neoadjuvant chemotherapy.
Patients who will diagnosed with clinically negative lymph node metastasis by using preoperative palpation, CT and MRI.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the quantitative measurement of blood vessel density by ultrasound with microbubbles enables the diagnosis of lymph nodes micrometastases in breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate whether the quantitative measurement of blood vessel density by contrast-enhanced ultrasound enables the diagnosis of lymph nodes micrometastases in breast cancer patients by setting appropriate threshold.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who will be diagnosed with breast cancer and be performed radical breast surgery.
Patients who will be performed surgery without neoadjuvant chemotherapy.
Patients who will not be diagnosed with lymph node metastasis by palpation, CT and MRI.
Key exclusion criteria
Patients who will have possibility of pregnancy or patients who will be breast-feeding woman.
Patients who will have allergy for contrast agent of ultrasound, egg and egg products.
Patients who will have right-to-left shunt.
Patients who will have severe heart disease or lung disease.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL
022-717-7312
naokomori7127@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL
022-717-7312
Homepage URL
naokomori7127@gmail.com
Sponsor or person
Institute
Diagnostic Radiology,Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS(Japan Society for promotion of Science)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 13 | 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
| 2013 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Contrast-enhanced ultrasound will be performed for patients with clinically negative lymph node metastasis.
After surgery, patients were classified into two groups (positive- and negative lymph node metastasis). We will evaluate whether contrast-enhanced ultrasound will differentiate negative- and positive group by using quantitative analysis.
Management information
Registered date
| 2016 | Year | 08 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027192
