RecruitingNot ApplicableNCT07426809

Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).


Sponsor

Royal College of Surgeons, Ireland

Enrollment

314 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Breast-conserving surgery is commonly performed to remove early-stage breast cancer or ductal carcinoma in situ (DCIS). During surgery, the goal is to completely remove the tumour with a clear margin of normal tissue around it. If cancer cells are found at the edge of the removed tissue (a "positive margin"), patients may need a second operation (re-excision). Re-excision can delay further treatment, increase patient anxiety, and increase healthcare costs. To help assess margins during surgery, surgeons use specimen imaging. Standard practice involves two-dimensional (2D) specimen mammography, usually performed in the radiology department. This requires temporary transfer of the specimen out of the operating theatre and provides limited depth information. The MOZART study is evaluating whether three-dimensional (3D) digital breast tomosynthesis, performed in the operating theatre using the Mozart system, improves margin assessment compared to standard 2D specimen mammography. Patients undergoing breast-conserving surgery at Beaumont Hospital who agree to participate will be randomly assigned (like flipping a coin) to one of two groups: Standard 2D specimen mammography (current standard practice), or 3D digital breast tomosynthesis performed in theatre. In both groups, the operating surgeon will review the images during surgery and decide whether additional tissue needs to be removed. The final margin status will be determined by routine laboratory analysis after surgery. The main goal of this study is to compare the rate of positive margins between the two imaging methods. Other outcomes include the need for additional surgery, operating time, and overall workflow efficiency. The results of this study may help determine whether intraoperative 3D imaging improves surgical outcomes and reduces the need for re-excision in patients undergoing breast-conserving surgery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (MOZART) is testing whether using real-time 3D imaging (tomosynthesis) during breast cancer surgery helps surgeons confirm that they have removed the entire tumor with clear margins, potentially reducing the need for second operations. **You may be eligible if...** - You are female and 18 years old or older - You have been diagnosed with primary invasive breast cancer or a pre-invasive condition called ductal carcinoma in situ (DCIS) - You are scheduled for breast-conserving (lumpectomy-type) surgery - There is no evidence of cancer spread to other parts of your body - You are fluent in English (spoken and written) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (stage IV) - You are having a mastectomy instead of breast-conserving surgery - You have had prior surgery on the same breast for the current cancer - You are participating in another interventional study affecting surgical margin assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard 2D Specimen Mammography

Two-dimensional specimen mammography performed intraoperatively in the radiology department to assess surgical margins following breast-conserving surgery. Images are reviewed by the operating surgeon to guide additional excision if indicated.

DEVICEMozart 3D Specimen Radiography System

Intraoperative digital breast tomosynthesis imaging performed in theatre using the Mozart 3D Specimen Radiography System (Kubtec). The system generates reconstructed 3D images of the excised specimen to allow real-time assessment of surgical margins by the operating surgeon.


Locations(1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, Ireland

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NCT07426809


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