UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of neoadjuvant chemotherapy for breast cancer using contrast-enhanced ultrasound (CE-US) imaging
Title of the study (Brief title)	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	Naoko Mori
Organization	Tohoku Univesity
Division name	Diagnostic Radiology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7312
Email	naokomori7127@gmail.com

Public contact
Name of contact person	Naoko Mori
Organization	Tohoku Univesity
Division name	Diagnostic Radiology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7312
Homepage URL
Email	naokomori7127@gmail.com

Sponsor
Institute	Diagnosis Radiology of Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025437