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

NCT07426809 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Standard 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.

DEVICE

Mozart 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.

Sponsors & Collaborators

  • Royal College of Surgeons, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Ireland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426809 on ClinicalTrials.gov