Clinical trial NCT04397029: 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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast
Screening
Elastography
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Sure, Inc.
First posted: 2020-05-21
Enrollment: 213
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: Primary
timeFrame: 2 years
Secondary outcomes:
measure: Secondary
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University - Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Rebecca Kaltman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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