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


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.

Full Title of Study: “Assessing the Sensitivity of “SureTouch™” in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 1, 2022

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).


  • Device: SureTouch
    • 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.

Arms, Groups and Cohorts

  • Experimental: Subjects without messes
    • Subjects who are believed to be free of masses.
  • Experimental: Subjects with known masses
    • Subjects with known masses.

Clinical Trial Outcome Measures

Primary Measures

  • Primary
    • Time Frame: 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 Measures

  • Secondary
    • Time Frame: 2 years
    • The study will determine the patient acceptance of and satisfaction with the SureTouch devise. Outcome measure will use a 9 question Likert scale survey to assess patient perception of the comfort, duration and acceptance of the SureTouch device.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rebecca Kaltman, MD
  • Collaborator
    • Sure, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Rebecca Kaltman, MD, Assistant Professor of Medicine – George Washington University
  • Overall Contact(s)
    • Christiane Morecock, 202-655-5955,


Cancer Stat Facts: Female Breast Cancer. Surveillance, Epidemiology, and End Results Program (SEER). Accessed July 2, 2018.

National Center for Health Statistics (NCHS). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville, MD. 2017.

Chang JM, Park IA, Lee SH, Kim WH, Bae MS, Koo HR, Yi A, Kim SJ, Cho N, Moon WK. Stiffness of tumours measured by shear-wave elastography correlated with subtypes of breast cancer. Eur Radiol. 2013 Sep;23(9):2450-8. doi: 10.1007/s00330-013-2866-2. Epub 2013 May 15.

Michaelson, James & Satija, Sameer & Moore, Richard & Weber, Griffin & Halpern, Elkan & Garland, Andrew & Kopans, Daniel & Hughes, Kevin. (2003). Estimates of the Sizes at Which Breast Cancers Become Detectable on Mammographic and Clinical Grounds. Journal of Women's Imaging. 5. 10.1097/00130747-200302000-00002.

Evans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Jordan L, Baker L, Thompson A. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res. 2010;12(6):R104. doi: 10.1186/bcr2787. Epub 2010 Dec 1.

Skovoroda, A.R., Klishko, A.N., Gusakyan, D.A., Mayevskii, Y.E., Yermilova, V.D.,Oranskaya, G.A. and Sarvazyan, A.P. 1995. Quantitative analysis of the mechanical characteristics of pathologically changed soft biological tissues. Biophsics, 40(6):1359-64.

Krouskop TA, Wheeler TM, Kallel F, Garra BS, Hall T. Elastic moduli of breast and prostate tissues under compression. Ultrason Imaging. 1998 Oct;20(4):260-74.

Sarvazyan A, Egorov V, Son JS, Kaufman CS. Cost-effective screening for breast cancer worldwide: current state and future directions. Breast Cancer (Auckl). 2008;1:91-9. Epub 2008 Jul 2.

Kaufman CS, Jacobson L, Bachman BA, Kaufman LB. Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record. Am J Surg. 2006 Oct;192(4):444-9.

Wellman PS, Dalton EP, Krag D, Kern KA, Howe RD. Tactile imaging of breast masses: first clinical report. Arch Surg. 2001 Feb;136(2):204-8.

Kaufman CS, et al., Objective measurement of the physical exam using a new device: reproducible triage of palpable masses. Breast Cancer Research and Treatment, 2004; 88; supp 1:S223-4- SABCS 2004.

Kaufman CS, Son JS, Yered E, Sarvazyan A. Cancer Res May 1 2015 (75) (9 Supplement) P1- 02-09; DOI:10.1158/1538-7445.SABCS14-P1-02-09

Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol. 2009 Oct;193(4):1124-7. doi: 10.2214/AJR.09.2520.

Heshmatzadeh Behzadi A, Farooq Z, Newhouse JH, Prince MR. MRI and CT contrast media extravasation: A systematic review. Medicine (Baltimore). 2018 Mar;97(9):e0055. doi: 10.1097/MD.0000000000010055. Review.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.