Breast Cancer
Conditions
Keywords
Breast, Screening, Elastography
Brief summary
Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
Detailed description
This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity. Results of the mammography will be compared to the SureTouch examination results. Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).
Interventions
DEVICESureTouch
The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment. The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both. Both groups will receive breast cancer screening with mammography and SureTouch.
Sponsors
Sure, Inc.
George Washington University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Arm 1: * Female Subject presenting for screening mammography * 30-80 years of age, inclusive * Able to provide written informed consent Arm 2: * Female Subject presenting for diagnostic appointment and/or biopsy * 30-80 years of age, inclusive * 1-3 masses per breast * Masses between 0.5 cm and 3.5 cm only
Exclusion criteria
* Individuals who are unable to comprehend or unwilling to sign an informed consent form * Women younger than 30 or older than 80 * Pregnant women * Women who have undergone bilateral mastectomies * Males * Prisoners * Masses which are larger than 3.5 cm or smaller than 0.5 cm in size * Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary | 2 years | 1\. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary | 2 years | The study will determine the patient acceptance of and satisfaction with the SureTouch devise. Outcome measure will use an original 8 question Likert-scale survey to assess patient perception of the comfort, duration, and acceptance of the device. A higher score indicates a better outcome. Brief Survey Monkey adapted from Press Ganey Patient Satisfaction Survey for Radiography and US Performed in the Outpatient Setting. Itri JN. Patient-centered Radiology. RadioGraphics 2015; 35:1835-1848 |
Countries
United States
Outcome results
None listed