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3D imaging could help surgeons remove all breast cancer in one go

NCT ID NCT05545150

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether a 3D imaging device, used during lumpectomy surgery, can help surgeons see and remove all cancerous tissue while the patient is still in the operating room. The goal is to reduce the chance of leaving cancer cells behind, which often leads to a second surgery. The study involves women with early-stage breast cancer or ductal carcinoma in situ who are scheduled for breast-conserving surgery.

What this could mean

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

Active substance
Clarix Imaging Volumetric Specimen Imager (VSI) - a 3D imaging device used during lumpectomy surgery
What this could lead to
If successful, this imaging approach could reduce the need for repeat breast cancer surgeries by helping surgeons remove all cancerous tissue in one operation.
What could go wrong
This is a phase II trial, so the imaging device may not prove accurate enough to replace standard methods. It is also limited to certain breast cancer patients, so results may not apply to everyone.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

113 people

The number who actually took part.

Started

Nov 2022

Finished

Mar 2025

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 with invasive breast cancer and/or ductal carcinoma in situ (DCIS) who will be undergoing breast conservation surgery, consisting of a lumpectomy or partial mastectomy procedure * Patients must be planning and able to undergo breast conservation surgery with planned localization (any localization device is eligible) and intraoperative imaging for the management of invasive breast cancer and/or DCIS. * Patients must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component. * The invasive breast cancer and/or DCIS lesion must have been visualized on mammography/ digital breast tomosynthesis (DBT), ultrasound (US), or magnetic resonance imaging (MRI). * Note: Patients with mammographically occult lesions are eligible, provided the lesion can be visualized using MRI or US. * Patients must be women who are \>= 18 years of age. * NOTE: Males and children under the age of 18 are not included in this study because the treatment paradigms for these groups are aggressive and routinely include mastectomy, whereas the present study is an investigation of breast conservation. * The patient (or the patient's legally authorized representative if the patient has impaired decision-making capacity) must have the ability to understand and provide voluntary written informed consent to participate in this study, prior to registration. * Patients who have received neoadjuvant chemotherapy for the treatment of breast cancer are eligible * Patients with bilateral breast cancer and/or multicentric disease are eligible. * Note: For these patients, the VSI device will only be used on a single lesion * Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational intervention for this trial are eligible. Exclusion Criteria: * Patients undergoing re-excision for invasive breast cancer or DCIS are not eligible * Patients who are expected to have an excised lumpectomy specimen that is larger than 9 cm x 9 cm x 7 cm are not eligible * Note: The specimen size limitation for the VSI device is 9 cm x 9 cm x 7 cm (length x width x height). * Patients must not have a physical or psychiatric illness, condition, or social circumstance that the investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • The University of Kentucky

    Lexington, Kentucky, 40536, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

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