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

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ClinicalTrials.gov Identifier: NCT04397029
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Sure, Inc.
Information provided by (Responsible Party):
Rebecca Kaltman, MD, George Washington University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: SureTouch Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Mammography

Arm Intervention/treatment
Experimental: Subjects without messes
Subjects who are believed to be free of masses.
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.


Experimental: Subjects with known masses
Subjects with known masses.
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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397029


Contacts
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Contact: Christiane Morecock 202-655-5955 cmorecock@mfa.gwu.edu

Locations
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United States, District of Columbia
George Washington University - Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Christiane Morecock    202-655-5955    cmorecock@mfa.gwu.edu   
Sub-Investigator: Anita Mehta, MD         
Sponsors and Collaborators
Rebecca Kaltman, MD
Sure, Inc.
Publications:
Cancer Stat Facts: Female Breast Cancer. Surveillance, Epidemiology, and End Results Program (SEER). https://seer.cancer.gov/statfacts/html/breast.html#skipnav. 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.
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.
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.
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

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Responsible Party: Rebecca Kaltman, MD, Assistant Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT04397029    
Other Study ID Numbers: GW10029
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rebecca Kaltman, MD, George Washington University:
Breast
Screening
Elastography
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases