UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022304
Receipt number R000025437
Scientific Title Evaluation of neoadjuvant chemotherapy for breast cancer using contrast-enhanced ultrasound (CE-US) imaging
Date of disclosure of the study information 2016/05/13
Last modified on 2017/05/19 13:30:12

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Basic information

Public title

Evaluation of neoadjuvant chemotherapy for breast cancer using contrast-enhanced ultrasound (CE-US) imaging

Acronym

Evaluation of neoadjuvant chemotherapy for breast cancer using CE-US imaging

Scientific Title

Evaluation of neoadjuvant chemotherapy for breast cancer using contrast-enhanced ultrasound (CE-US) imaging

Scientific Title:Acronym

Evaluation of neoadjuvant chemotherapy for breast cancer using CE-US imaging

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of contrast-enhanced ultrasound to evaluate the change of perfusoin during neoadjuvant chemotherapy for breast cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare the quantitative parameters from contrast-enhanced ultrasound in pre-, 3 weeks, 12 weeks and 21 weeks after NAC between responders and non-responders.

Key secondary outcomes

1.To evaluate the possibility of non-contrast Doppler ultrasound imaging to evaluate the effectiveness of NAC.

2. To evaluate the possibility of contrast-enhanced and non-contrast Doppler ultrasound imaging to evaluate the effectiveness of NAC in lymph node metastases.

3. To evaluate the possibility of diffusion weighted imaging and dynamic contrast-enhanced imaging from MRI to evaluate the effectiveness of NAC in primary breast cancer lymph node metastases.To evaluate which parameters from contrast-enhanced ultrasound or MRI would be the best to predict the effectiveness of NAC.


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 are performed neoadjuvant chemotherapy before surgery for breast cancer will be included if informed consent will be obtained.
The diagnosis of breast cancer will be made using imaging findings including mammography, non-contrast enhanced ultrasound and dynamic MRI and needle biopsy.
The objective of this study is one lesion which can be detected by B-mode ultrasound clearly from each patient. In patients with multiple or bilateral lesions, the lesion with largest diameter will be targeted.

Key exclusion criteria

Exclusion criteria is
1. Patients who are pregnant or breast-feeding.
2. Patients who have allergy to Sonazoid.
3. Patients who have allergy to egg.
4. Patients who have pulmonary arteriovenous shunt or right-to-left shunt.
5. Patients who have severe heart or lung disease.
6. Patients to whom contrast-enhanced CT or MRI can not be performed due to renal failure.
7. Patients who have mental disease.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Mori

Organization

Tohoku Univesity

Division name

Diagnostic Radiology

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-7312

Email

naokomori7127@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Naoko Mori

Organization

Tohoku Univesity

Division name

Diagnostic Radiology

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-7312

Homepage URL


Email

naokomori7127@gmail.com


Sponsor or person

Institute

Diagnosis Radiology of Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Kakenhi

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


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



Other administrative information

Date of disclosure of the study information

2016 Year 05 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

Preinitiation

Date of protocol fixation

2016 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 05 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

This study is a observatory study to evaluate the effectiveness of quantative analysis for contrast enhanced ultrasound for patients who will be performed with neoadjuvant chemotherapy before surgery.


Management information

Registered date

2016 Year 05 Month 13 Day

Last modified on

2017 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025437


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name