Delphinus SoftVue Prospective Case Collection - ARM 2

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. (If clinically indicated)
• Digital breast tomosynthesis (DBT), FDA Approved for breast screening and diagnosis, various manufacturers.
• Handheld Ultrasound (HHUS), FDA-Cleared for diagnostic breast imaging, various manufacturers. (If clinically indicated)
• Other diagnostic tests and medical device examinations of the breast, including, but not limited to MRI, BSGI, PET, biopsy, and elastography, on the order of a licensed physician, when clinically indicated.

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 1,000 total enrolled subjects

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 diagnostic evaluation or biopsy at multiple clinical sites.
• All participants will complete the same standard care diagnostic evaluations that were recommended by a physician
• Eligible patients will receive a SV scan at the time of their scheduled diagnostic appointments, preferably prior to biopsy
• Investigators at the sites will compare SV images to the accompanying diagnostic images and pathology results
• No clinical SV interpretation will be performed and no clinical interventions will be made or changed based on SV images
• All evaluation results, diagnosis and treatment outcomes will be recorded
• Cancer status for all participants will be surveyed from program entry until and including the completion of physician recommended diagnostic workup
• A case will be determined cancer negative if the participant has non-malignant breast biopsy findings or confirmed non-suspicious diagnostic breast imaging findings
• A case will be determined cancer positive if a pathological evaluation confirms a breast cancer diagnosis (malignancy)

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.

Inclusion criteria

• Female
• Any race or ethnicity
• Age 18 or older
• Findings of concern on clinical breast exam or imaging
• Scheduled for diagnostic imaging, needle biopsy, excisional biopsy, or post-needle-biopsy visit
• Diagnostic imaging assessment category BI-RADS 4 or 5 and willing to undergo biopsy(ies) or, per the Principal Investigator, subject's case would be beneficial for use in the lesion atlas or teaching library
• Agrees to be contacted by site staff if a recommended biopsy is not completed within the appropriate time frame

Exclusion criteria

• Unwilling/unable to comply with the protocol and follow-up recommendations
• Lumpectomy or excisional biopsy of the primary region of interest performed prior to SoftVue imaging, such that there are not sufficient findings to make the case useful for the lesion atlas or teaching library
• 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