Delphinus SoftVue Prospective Case Collection - ARM 1 (SV PCC ARM1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03257839|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Last Update Posted : January 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Device: Routine Full-Field Digital Mammography Device: Routine Digital Breast Tomosynthesis Device: Automated Whole Breast Ultrasound|
|Study Type :||Observational|
|Actual Enrollment :||10000 participants|
|Official 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.|
|Actual Study Start Date :||July 31, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
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
Routine screening mammography exam, CC + MLO views.
Other Name: FFDM, Digital Mammography, Mammography
Device: Routine Digital Breast Tomosynthesis
Routine screening tomosynthesis exam, CC + MLO views.
Other Name: DBT, 3D Mammography, Tomosynthesis
Device: Automated Whole Breast Ultrasound
Bilateral breast ultrasound performed as an adjunct to mammography.
Other Name: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US
- No Breast Cancer [ Time Frame: 365 Days ]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
- Breast Cancer [ Time Frame: 365 Days ]Cancer cases, confirmed by breast biopsy with malignant pathology, within 365 days of follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257839
|United States, California|
|Lee Breast Center, USC Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Miami Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Georgia|
|Savannah, Georgia, United States, 31406|
|United States, Michigan|
|Beaumont Health, Dearborn Breast Care Center, Oakwood Women's Health Center|
|Dearborn, Michigan, United States, 48374|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15220|
|United States, Wisconsin|
|Saint Elizabeth Hospital|
|Appleton, Wisconsin, United States, 54915|
|Principal Investigator:||Linda H Larsen, MD||Keck School of Medicine, University of Southern California|