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

Information

  • Research Project
  • 9461025
  • ApplicationId
    9461025
  • Core Project Number
    R44CA165320
  • Full Project Number
    5R44CA165320-06
  • Serial Number
    165320
  • FOA Number
    RFA-CA-15-010
  • Sub Project Id
  • Project Start Date
    12/1/2011 - 13 years ago
  • Project End Date
    3/31/2019 - 6 years ago
  • Program Officer Name
    NARAYANAN, DEEPA
  • Budget Start Date
    4/1/2018 - 7 years ago
  • Budget End Date
    3/31/2019 - 6 years ago
  • Fiscal Year
    2018
  • Support Year
    06
  • Suffix
  • Award Notice Date
    3/31/2018 - 7 years ago

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

? DESCRIPTION (provided by applicant): Recent studies have demonstrated the effectiveness of hand held ultrasound imaging in detecting breast cancer, particularly for women with dense breasts. The latest reports have shown the potential to screen for small breast masses otherwise missed by mammography with up to 4.5 extra cancers detected per 1000 screens. A 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 detection. Despite these successes, handheld ultrasound is unlikely to be adopted for screening because it is operator-dependent, and its imaging aperture is small, which hinders whole breast imaging. To that end, automated breast ultrasound (ABUS) has been introduced as a way of overcoming these issues, mainly by reducing operator dependence and increasing the field of view. Unfortunately adoption of ultrasound screening has been slow. One major reason is that ABUS screening increases call back rates (up to a factor of 2 in case of the SomoInsight study). With its basic B-mode capability, it is unlikely that ABUS will be widely adopted for primary screening in the foreseeable future without more tissue-specific imaging capability. Improved lesion characterization would help lower the barriers to adoption of screening ultrasound. Our recently completed Fast Track grant demonstrated improved lesion characterization through tissue specific imaging in a diagnostic setting. These results suggest that improved specificity may therefore be realized in a screening setting, paving the way for screening trials as a natural extension of the activities under the parent grant. The objective of this study, therefore, is to characterize SoftVue's screening performance in the general population of women with dense breasts. The central hypothesis is that the area under the Receiver Operating Characteristic (ROC) curve is increased when digital mammography and SoftVue are used together versus mammography alone. The hypothesis will be tested by carrying out a multi-center clinical trial of 10,000 asymptomatic women having breast density categories of c and d. The trial will consist of a data collection phase at 6 sites across the US, followed by a pivotal reader study utilizing > 20 readers. The 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 ultrasound. The 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 screening. The following specific aims will guide our study.

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R44
  • Administering IC
    CA
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    857782
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    394
  • Ed Inst. Type
  • Funding ICs
    NCI:857782\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZCA1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    DELPHINUS MEDICAL TECHNOLOGIES, INC.
  • Organization Department
  • Organization DUNS
    963425017
  • Organization City
    NOVI
  • Organization State
    MI
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    483741308
  • Organization District
    UNITED STATES