TerminatedNot Applicable

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

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.

United States213 participantsStarted 2019-01-04

Plain-language 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.

Who can participate

Age range

30 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary

Timeframe: 2 years

Trial details

NCT IDNCT04397029

SponsorGeorge Washington University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-10

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