Delphinus SoftVue Prospective Case Collection - ARM 2 (SV PCC ARM2)
|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: NCT02977247|
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2016
Last Update Posted : February 9, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Other: Non-Interventional Device: Automated Whole Breast Ultrasound|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||ARM 2: 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.|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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).
Only standard care procedures will be performed for clinical intervention and diagnostic purposes.
Other Name: Standard Medical Care
Device: Automated Whole Breast Ultrasound
Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.
Other Name: SoftVue, AWBUS, ABUS, 3D Breast Ultrasound, 3D ABUS, 3D Ultrasound, 3D US
- No Breast Cancer [ Time Frame: Current Diagnostic Evaluation Episode, 0 to 60 Days ]Non‐Cancer cases, confirmed by normal or negative breast imaging findings or concordant breast biopsy with benign pathology.
- Breast Cancer [ Time Frame: Current Diagnostic Evaluation Episode, 0 to 60 Days ]Cancer cases, confirmed by breast biopsy with malignant pathology
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): NCT02977247
|United States, New York|
|Elizabeth Wende Breast Care|
|Rochester, New York, United States, 14620|
|Principal Investigator:||Linda H Larsen, MD||Keck School of Medicine, University of Southern California|