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

June 9, 2022 updated by: George Washington University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University - Medical Faculty Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary
Time Frame: 2 years

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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Collaborators

Sure, Inc.

Investigators

  • Principal Investigator: Rebecca Kaltman, MD, The George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

February 10, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW10029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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