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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SureTouch

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Breast, Screening, Elastography

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

George Washington University - Medical Faculty Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Subjects without messes

Subjects with known masses

Arm Description

Subjects who are believed to be free of masses.

Subjects with known masses.

Outcomes

Primary Outcome Measures

Primary

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

Secondary

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

Full Information

NCT ID

NCT04397029

First Posted

March 11, 2020

Last Updated

June 9, 2022

Sponsor

George Washington University

Collaborators

Sure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04397029

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

The benefit of completing the study was not worth exposing subjects to the risk during COVID. Delaying the return visits would make it difficult to analyze the changes in data overtime.

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

February 10, 2021 (Actual)

Study Completion Date

February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

George Washington University

Collaborators

Sure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast, Screening, Elastography

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects without messes

Arm Type

Experimental

Arm Description

Subjects who are believed to be free of masses.

Arm Title

Subjects with known masses

Arm Type

Experimental

Arm Description

Subjects with known masses.

Intervention Type

Device

Intervention Name(s)

SureTouch

Intervention Description

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 Measure Information:

Title

Primary

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Secondary

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Kaltman, MD

Organizational Affiliation

The George Washington University

Official's Role

Principal Investigator

Facility Information:

Facility Name

George Washington University - Medical Faculty Associates

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

Citation

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.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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