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

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.

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).

Interventions

  • 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, cmorecock@mfa.gwu.edu

References

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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.

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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.

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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.

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