Toward a screening designation for SoftVue: A multi-center clinical trial in support of Pre-Market Approval.

DESCRIPTIONprovided by applicantRecent studies have demonstrated the effectiveness of hand held ultrasound imaging in detecting breast cancerparticularly for women with dense breastsThe latest reports have shown the potential to screen for small breast masses otherwise missed by mammography with up toextra cancers detected perscreensA striking aspect of the added detections is that they are predominantly node negative invasive cancers which would have progressed to a later stage before possible mammographic detectionDespite these successeshandheld ultrasound is unlikely to be adopted for screening because it is operator dependentand its imaging aperture is smallwhich hinders whole breast imagingTo that endautomated breast ultrasoundABUShas been introduced as a way of overcoming these issuesmainly by reducing operator dependence and increasing the field of viewUnfortunately adoption of ultrasound screening has been slowOne major reason is that ABUS screening increases call back ratesup to a factor ofin case of the SomoInsight studyWith its basic B mode capabilityit is unlikely that ABUS will be widely adopted for primary screening in the foreseeable future without more tissue specific imaging capabilityImproved lesion characterization would help lower the barriers to adoption of screening ultrasoundOur recently completed Fast Track grant demonstrated improved lesion characterization through tissue specific imaging in a diagnostic settingThese results suggest that improved specificity may therefore be realized in a screening settingpaving the way for screening trials as a natural extension of the activities under the parent grantThe objective of this studythereforeis to characterize SoftVue s screening performance in the general population of women with dense breastsThe central hypothesis is that the area under the Receiver Operating CharacteristicROCcurve is increased when digital mammography and SoftVue are used together versus mammography aloneThe hypothesis will be tested by carrying out a multi center clinical trial ofasymptomatic women having breast density categories of c and dThe trial will consist of a data collection phase atsites across the USfollowed by a pivotal reader study utilizing rtreadersThe expected outcome of the study is an increase in the detection of invasive cancers compared to mammography and a reduction in call back rates compared to current ultrasoundThe rationale for the proposed study is that a successful trial outcome will lead to FDA per Market Approval which would enable Delphinus to market SoftVue for supplemental screeningThe following specific aims will guide our study