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

George Washington University213 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

213

Conditions

Breast Cancer

Interventions

SureTouchDEVICE

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

George Washington University - Medical Faculty Associates

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

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