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Trial record 3 of 7 for:    Yamashita | breast cancer

Delphinus SoftVue Prospective Case Collection - ARM 1 (SV PCC ARM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03257839
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):
Delphinus Medical Technologies, Inc.

Brief Summary:

The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography.

SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device.

This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801.

Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data.

The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.

Condition or disease Intervention/treatment
Breast Neoplasms Device: Routine Full-Field Digital Mammography Device: Routine Digital Breast Tomosynthesis Device: Automated Whole Breast Ultrasound

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Study Type : Observational
Actual Enrollment : 7409 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: ARM 1: A Prospective, Multicenter, Multi-arm, Clinical Case Collection Program to Acquire Breast Image Data and Establish an Image Library of Exams for Use in Future Research Studies, Training, and Product Development Efforts.
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Asymptomatic women with dense breast tissue
Healthy women presenting to enrollment sites for routine annual mammographic examinations, confirmed to have BI-RADS category c or d breast composition (density).
Device: Routine Full-Field Digital Mammography
Routine screening mammography exam, CC + MLO views.
Other Name: FFDM, Digital Mammography, Mammography

Device: Routine Digital Breast Tomosynthesis
Routine screening tomosynthesis exam, CC + MLO views.
Other Name: DBT, 3D Mammography, Tomosynthesis

Device: Automated Whole Breast Ultrasound
Bilateral breast ultrasound performed as an adjunct to mammography.
Other Name: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US

Primary Outcome Measures :
  1. No Breast Cancer [ Time Frame: 365 Days ]
    Non-Cancer cases, confirmed by normal or negative mammographic breast imaging (FFDM or DBT), or breast biopsy with benign pathology, after at least 365 days of follow-up

  2. Breast Cancer [ Time Frame: 365 Days ]
    Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Asymptomatic women with dense breast tissue

Inclusion Criteria

  • Female
  • Any race or ethnicity
  • Age 18 or older
  • Asymptomatic
  • Complete screening FFDM and DBT views
  • BI-RADS density composition category c or d
  • Willing to comply with protocol and follow-up recommendations as described in consent form, including the next annual screening exam in 12 months

Exclusion Criteria

  • Weight exceeds 350lbs
  • Currently pregnant or lactating by patient self-report
  • Weeping rash, open wounds, or unhealed sores on the breast
  • Bilateral mastectomy
  • Unable to lay prone on the scan table for up to 15 minutes
  • History of breast cancer diagnosis and/or treatment (chemotherapy, surgery, and/or radiation) in the past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03257839

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United States, California
USC Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
SouthCoast Imaging
Savannah, Georgia, United States, 31406
United States, Michigan
Beaumont Dearborn Breast Care Center
Dearborn, Michigan, United States, 48124
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Mercy Imaging Services
Washington, Missouri, United States, 93090
United States, New York
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620
United States, North Carolina
UNC Breast Imaging Center
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Weinstein Imaging Associates
Pittsburgh, Pennsylvania, United States, 15220
United States, Wisconsin
Ascension St. Elizabeth, Radiology Associates of the Fox Valley
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
Delphinus Medical Technologies, Inc.
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Principal Investigator: Mary W Yamashita, MD Keck School of Medicine, University of Southern California
Additional Information:

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Responsible Party: Delphinus Medical Technologies, Inc. Identifier: NCT03257839    
Other Study ID Numbers: DMT-2015.001 ARM 1
Protocol ID: 20151525 ( Other Identifier: Western IRB )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Delphinus Medical Technologies, Inc.:
Dense Breast Tissue
Breast Screening
Abnormal Breast
Normal Breast
Breast Imaging
Breast Biopsy
Automated Breast Ultrasound
Breast Cancer
Breast Carcinoma
Breast Tumors
Mammary Carcinoma
Malignant Breast Tumor
Mammary Neoplasm
Mammary Cancer
Breast Tomography
3D Breast Ultrasound
Breast Ultrasound
Dense Breasts
Breast Density
Screening Breast Ultrasound
3D Mammogram
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases