Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Subjects who are believed to be free of masses.

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.

SureTouch

Rebecca Kaltman, MD

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).

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

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

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography	NCT04397029	Breast Cancer	SureTouch	30 Years - 80 Years	George Washington University
Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography	NCT04397029	Breast Cancer	SureTouch	30 Years - 80 Years	George Washington University

Spots Global Cancer Trial Database for suretouch

Every month we try and update this database with for suretouch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for suretouch

Every month we try and update this database with for suretouch cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for suretouch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.