Assessing the Sensitivity of SureTouch™ in Women Undergoing Diagnostic and Screening Mammography

Study Overview
=================
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).

Official Title
-----------------
Assessing the Sensitivity of SureTouch™ in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: SureTouch


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects without messes<br>Subjects who are believed to be free of masses. | Device: SureTouch<br>* 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.<br>|
| Experimental: Subjects with known masses<br>Subjects with known masses. | Device: SureTouch<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary | 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 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Screening, Elastography