Breast Neoplasms Clinical Trial
— SV PCC ARM1Official 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.
Verified date | August 2021 |
Source | Delphinus Medical Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7409 |
Est. completion date | July 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ascension St. Elizabeth, Radiology Associates of the Fox Valley | Appleton | Wisconsin |
United States | UNC Breast Imaging Center | Chapel Hill | North Carolina |
United States | Beaumont Dearborn Breast Care Center | Dearborn | Michigan |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | USC Keck School of Medicine | Los Angeles | California |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | Weinstein Imaging Associates | Pittsburgh | Pennsylvania |
United States | Elizabeth Wende Breast Care | Rochester | New York |
United States | SouthCoast Imaging | Savannah | Georgia |
United States | Mercy Imaging Services | Washington | Missouri |
Lead Sponsor | Collaborator |
---|---|
Delphinus Medical Technologies, Inc. |
United States,
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* Note: There are 50 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Breast Cancer | Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up | 365 Days |
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