CompletedNot Applicable

Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

United States613 participantsStarted 2021-12-01

Plain-language summary

This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.

Who can participate

Age range

18 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 18 years or older * Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ * May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Male * Metastatic cancer (Stage IV) * Lobular carcinoma as primary diagnosis * Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation) * Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen * Subjects with bilateral disease (diagnosed cancer in both breasts) * Participating in any other investigational margin assessment study which can influence collection of valid data under this study * Use of cryo-assisted localization * Currently lactating * Current pregnancy * Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging

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

Participants With at Least One Unaddressed Positive Margin

Timeframe: Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)

Trial details

NCT IDNCT05113927

SponsorPerimeter Medical Imaging

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-23

Results submitted2026-03-31

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