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New study aims to spare healthy breast tissue during cancer surgery

NCT ID NCT05825482

Disease control Sponsor: Case Comprehensive Cancer Center 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study compares two surgical approaches for breast cancer: one that removes extra tissue around the tumor (routine cavity shave margins) and one that uses a special device (Savi Scout®) to guide removal of only suspicious margins. About 204 women with early-stage breast cancer will take part. The goal is to see which method better ensures all cancer is removed while removing less healthy tissue, potentially lowering the need for repeat surgeries.

What this could mean

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

Active substance
Savi Scout® localization device
What this could lead to
If successful, this could help surgeons remove breast cancer more precisely, reducing the need for additional surgeries and preserving more healthy breast tissue.
What could go wrong
This is a relatively small, early-stage study (204 participants) comparing surgical techniques, not testing a new drug. Results may not apply to all breast cancer types or hospitals.

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

32 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 * Women 18 years and older, and * With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and * That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and * Present to Cleveland Clinic Akron General. * Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ. * Performance status: ECOG 0-1 * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Patients may have received or may be receiving endocrine therapy. Exclusion Criteria * Men * Pregnant women * Patients who have received neoadjuvant chemotherapy for current cancer diagnosis. * Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.) * Patients \< 18 years of age.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive 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

  • Cleveland Clinic Akron General, Case Comprehensive Cancer Center

    Akron, Ohio, 44302, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.