UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study to evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Acronym	FLOW-CEUS 01
Scientific Title	Multicenter study to evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Scientific Title:Acronym	FLOW-CEUS 01
Region	Japan

Condition
Condition	breast cancer and breast benign lesion
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Basic objectives2	Others
Basic objectives -Others	To create the evaluation criteria of the contrast-enhanced ultrasound pattern for differential diagnosis (benign vs malignant) of local breast lesions
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The concordance rate of the evaluation of the pattern on CEUS among the blind readers
Key secondary outcomes	The sensitivity, specificity, accuracy and certainty factor of the CEUS and unenhanced ultrasound (B-mode)

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) A breast mass (lesion on interest) underwent CEUS. 2) Pathologically proved breast mass after CEUS. 3) A breast mass less than 3 cm in diameter by unenhanced ultrasound.
Key exclusion criteria	1)Patients who were underwent anticancer therapy, including chemotherapy or radiation therapy before breast CEUS. 2)Any other conditions that made the patient unsuitable for participation in this study according to each principal investigator or subinvestigator.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	634-8522
Address	840 Shijo-cho Kashihara Nara
TEL	0744-22-3051
Email	takasi@naramed-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	634-8522
Address	840 Shijo-cho Kashihara Nara
TEL	0744-22-3051
Homepage URL
Email	takasi@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	The Japan association of Breast and Thyroid Sonology
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	Nara Medical University
Address	840 Shijo-cho Kashihara Nara
Tel	0744-22-3051
Email	ino_rinri@naramed-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

Other administrative information
Date of disclosure of the study information	2017 Year 03 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	222
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to the delay in analyzing the results
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	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 20 Day
Date of IRB	2015 Year 12 Month 28 Day
Anticipated trial start date	2016 Year 08 Month 31 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is being conducted as a research group of Japan Association of Breast and Thyroid Sonology.

Management information
Registered date	2017 Year 02 Month 24 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030197