Delphinus SoftVue Prospective Case Collection - ARM 1

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.

MEDICAL DEVICES:

* SoftVue™ (SV) automated whole breast ultrasound system, 510(k) Cleared for B-Mode ultrasound breast imaging, manufactured by Delphinus Medical Technologies.
* SoftVue™ with device modifications (software, hardware, user-interface), safety-tested for human use to complete feasibility, verification, and validation testing as a routine part of product development and performed in accordance with FDA 21 CFR 812.2 (b), manufactured by Delphinus Medical Technologies.
* Full-field digital mammography (FFDM), FDA Approved for breast screening and diagnosis, various manufacturers.
* Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.

OBJECTIVES:

* Primary: To establish a library of cases for use in future SoftVue™ research studies, user training, and marketing.
* Secondary: Determine the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue.

ENDPOINTS:

From multiple clinical sites whichever comes first:

* Up to 17,500 total enrolled subjects
* Up to 105 total breast cancer cases detected at program entry screening
* At least 35 total discordant breast cancer cases, where FFDM is negative or benign (BI-RADS 1 or 2) but SV is incomplete (BIRADS 0) and diagnostic imaging workup of SV findings leads to breast biopsy with malignant pathology

SITES:

At least six (≥ 6) qualified clinical sites in the United States

* MQSA Certified
* Digital Breast Tomosynthesis Screening Program Implemented
* Academic, Community Hospital, or Private Practice Setting

PROJECT DESIGN AND PROCEDURES:

* Potential participants will be recruited from the group of women presenting for their annual breast imaging exams at multiple clinical sites utilizing 3D DBT and 2D FFDM (non-synthesized) for routine screening.
* Asymptomatic women with heterogeneously or extremely dense breast parenchyma (BI-RADS composition c or d), based on visual assessment of FFDM by trained site personnel, will be invited to consider volunteering to participate in the case collection program.
* All participants will complete the same routine screening FFDM + DBT evaluation for which they originally reported to the clinic, with a complete set of 2D views and 3D views.
* Eligible patients will receive SV as an adjunct to FFDM + DBT.
* A single Investigator (radiologist) at each site will perform sequential review of the same subjects FFDM, DBT, and SV images.
* FFDM will be evaluated for final parenchymal density (BI-RADS a through d) and then each exam will be assigned to one of 3 BI-RADS assessment categories (0, 1, 2) by the radiologist.
* Abnormal findings will be indicated by a BI-RADS assessment category of 0 (Incomplete)and will undergo diagnostic imaging evaluations consistent with universally accepted standards of care.
* All evaluation results, diagnosis and treatment outcomes will be recorded.
* Normal findings will be indicated by BI-RADS assessment categories of 1 or 2 (Negative or Benign) which will be associated with a management recommendation to resume routine screening in one year, unless symptoms or signs of breast cancer develop in the interim.
* All participants who are not diagnosed with breast cancer as a direct result of the program entry examinations, incidental evaluations, or interval symptoms, will return to the site in 12 months for their next annual screening exam, the results and outcome of which will be recorded.
* Cancer status for all participants will be surveyed from program entry until and including the completion of recommended follow-up.
* A case will be determined cancer negative if the participant has no findings suspicious for cancer throughout the interval between program entry and completion of annual follow-up.
* A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis during the interval between program entry and completion of annual follow-up.

STATISTICAL ANALYSIS:

* Demographic characteristics (age, race, and ethnicity) and other baseline characteristics (e.g., project arm, project site, breast density, lesion-specific characteristics) will be tabulated for all participants.
* A flow diagram or table will illustrate patient disposition ("accountability of patient cohort") including reasons for ineligibility and/or unevaluability.
* Safety will be summarized for all enrolled women. With the exception of anticipated events, adverse events (AEs) and serious adverse events (SAEs), occurring from the time of enrollment (SoftVue) and for 24 hours following the conclusion of the SoftVue exam, will be recorded.
* A separate statistical plan will be developed for any future analysis that includes justification of sample size and, if applicable to the requirements of FDAAA 801, will be registered separately in order to share the results.

Eligibility Criteria:
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