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New imaging tool aims to cut repeat surgeries in breast cancer

NCT ID NCT05113927

Disease control Sponsor: Perimeter Medical Imaging Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests a device called SELENE that gives surgeons a detailed view of the tissue removed during breast-conserving surgery. The goal is to see if using this imaging helps surgeons remove all cancer cells the first time, reducing the chance that a patient needs another operation. The study involves women with early-stage breast cancer who are having lumpectomy surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SELENE imaging device
What this could lead to
If successful, this device could help surgeons remove all cancer in one operation, reducing the need for additional surgeries and improving outcomes for breast cancer patients.
What could go wrong
The device is still being tested, and it may not significantly reduce positive margin rates. It also adds time to the surgery and may not work for all types of breast cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

613 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive ductal breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Holy Redeemer

    Meadowbrook, Pennsylvania, 19046, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Methodist Healthcare of San Antonio

    San Antonio, Texas, 78229, United States

  • Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138, United States

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