Delphinus SoftVue Prospective Case Collection - ARM 1

NCT03257839 | Completed FDA Device

• 2 other identifiers: DMT-2015.001 ARM 1Protocol ID: 20151525
• Study Type: observational
• Target: 7,409
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Neoplasms

Keywords

SoftVue; Dense Breast Tissue; Breast Screening; Abnormal Breast; Normal Breast; Breast Imaging; Breast Biopsy; Mammography; Tomosynthesis; Automated Breast Ultrasound; Breast Cancer; Breast Carcinoma; Breast Tumors; Mammary Carcinoma; Malignant Breast Tumor; Mammary Neoplasm; Mammary Cancer; ABUS; AWBUS; Breast Tomography; ATUS; ABTUS; Mammogram; 3D Mammogram; 3D ABUS; 3D Breast Ultrasound; DBT; FFDM; Digital Mammography; Breast Ultrasound; Dense Breasts; Breast Density; Dense Parenchyma; Asymptomatic; Delphinus; Delphinus Medical Technologies; Screening Breast Ultrasound

Outcome Measures

Primary Outcomes (2)

• No Breast Cancer

  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

  365 Days

• Breast Cancer

  Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up

  365 Days

Study Arms (1)

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; Device: Routine Digital Breast Tomosynthesis; Device: Automated Whole Breast Ultrasound

Interventions

Routine Full-Field Digital Mammography DEVICE

Routine screening mammography exam, CC + MLO views.

Also known as: FFDM, Digital Mammography, Mammography

Asymptomatic women with dense breast tissue

Routine Digital Breast Tomosynthesis DEVICE

Routine screening tomosynthesis exam, CC + MLO views.

Also known as: DBT, 3D Mammography, Tomosynthesis

Asymptomatic women with dense breast tissue

Automated Whole Breast Ultrasound DEVICE

Bilateral breast ultrasound performed as an adjunct to mammography.

Also known as: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US

Asymptomatic women with dense breast tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asymptomatic women with dense breast tissue

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Delphinus Medical Technologies, Inc.: lead

Study Sites (10)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

SouthCoast Imaging

Savannah, Georgia, 31406, United States

Location

Beaumont Dearborn Breast Care Center

Dearborn, Michigan, 48124, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mercy Imaging Services

Washington, Missouri, 93090, United States

Location

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Location

UNC Breast Imaging Center

Chapel Hill, North Carolina, 27514, United States

Location

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, 15220, United States

Location

Ascension St. Elizabeth, Radiology Associates of the Fox Valley

Appleton, Wisconsin, 54911, United States

Location

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Related Links

• Delphinus Medical Technologies

MeSH Terms

Conditions

Breast Neoplasms; Mammary Neoplasms, Animal

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mary W Yamashita, MD

  Keck School of Medicine, University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: July 31, 2017
• Primary Completion: January 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

US (10)