CompletedNot Applicable

Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study

United States287 participantsStarted 2014-07

Plain-language summary

Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.

Who can participate

Age range

25 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: * Female * Age 25 or older * A bra cup size of A through DDD * Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s) * Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst * Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO) for one or both breasts * Mammographically-detected lesion(s) seen on at least one mammographic view and a corresponding HHUS correlate(s) Exclusion Criteria: * Does not meet all Inclusion Criteria * Currently breastfeeding * History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration * History of breast surgeries or interventional breast procedures in the past 12 months * Normal mammogram at the time of this evaluation * Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time * Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast * Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner * Body weight greater than 400 lbs. (180 kg) * Has a concurrent disease or condition which in the judgment of the principal investigator disqualifies the subject, fr…

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

The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology.

Timeframe: 12 months

Trial details

NCT IDNCT02133417

SponsorQT Ultrasound LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Mass Lesion trials