Delphinus SoftVue Prospective Case Collection - ARM 2

NCT02977247 | Completed

• 2 other identifiers: DMT-2015.001 ARM 2Protocol ID: 20151525
• Study Type: observational
• Target: 1,150
• 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 2 aims to collectively enroll up to 1,000 women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly limited to case collection and is non-interventional; any investigational and/or statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 2 is limited to the cohort of diagnostic female patients of any breast density composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic imaging and SV exams, from the same patient, demographic information, and clinical outcome data, will be collected during diagnostic workup. 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. Ultrasound image data may be acquired with modified SoftVue devices, which have passed safety and quality evaluations per Delphinus' quality management system (QMS) and satisfy design change control standards, at select clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility, validation, and verification testing for engineering and product development purposes. 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 curricula, building teaching case, and creating new marketing materials 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; Diagnostic Breast Imaging

Outcome Measures

Primary Outcomes (2)

• No Breast Cancer

  Non-Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.

  Current Diagnostic Evaluation Episode, 0 to 60 Days

• Breast Cancer

  Cancer cases, confirmed by breast biopsy with malignant pathology

  Current Diagnostic Evaluation Episode, 0 to 60 Days

Study Arms (1)

Women undergoing routine diagnostic breast evaluation

Non-Interventional: Women presenting to enrollment sites for diagnostic examinations of symptoms or imaging findings, as recommended by a physician, and assigned BI-RADS category 4 or 5 (biopsy indicated).

Other: Non-Interventional; Device: Automated Whole Breast Ultrasound

Interventions

Non-Interventional OTHER

Only standard care procedures will be performed for clinical intervention and diagnostic purposes.

Also known as: Standard Medical Care

Women undergoing routine diagnostic breast evaluation

Automated Whole Breast Ultrasound DEVICE

Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.

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

Women undergoing routine diagnostic breast evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Arm 2 is limited to the cohort of diagnostic women of any breast density composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic imaging. Matched sets of diagnostic imaging with DBT\* and SV exams from the same patient, demographic information, and clinical outcome data, will be collected during diagnostic workup. 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. Ultrasound image data may be acquired with modified SoftVue devices, which have passed safety and quality evaluations per Delphinus' quality management system (QMS) and satisfy design change control standards, at select clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility, validation, and verification testing for engineering and product development purposes.

You may qualify if:

• 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

You may not qualify if:

• 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

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

Condition Hierarchy (Ancestors)

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

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: November 23, 2016
• First Posted: November 30, 2016
• Study Start: December 6, 2016
• Primary Completion: October 31, 2019
• Study Completion: July 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)