3D imaging could help surgeons remove all breast cancer in one go
NCT ID NCT05545150
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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113 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Mar 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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The University of Kentucky
Lexington, Kentucky, 40536, United States
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Washington University in St. Louis
St Louis, Missouri, 63110, United States
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