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

NCT07426809 | Recruiting DMC

• 1 other identifier: 25-61
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast Cancer; MOZART

Outcome Measures

Primary Outcomes (1)

• Rate f positive Surgical Margins

  Proportion of participants with positive margins on final histopathological assessment following breast-conserving surgery. A positive margin is defined as: Invasive carcinoma at or within 1 mm of the inked surgical margin, or Ductal carcinoma in situ (DCIS) within 2 mm of the inked margin. Margin status will be determined by blinded histopathological evaluation of the surgical specimen.

  Within 4 weeks after index surgery (upon availability of final histopathology report)

Secondary Outcomes (5)

• Re-Excision Rate

  Within 3 months after index surgery

• Time From Specimen Removal to Imaging Review

  Intraoperative (day of surgery)

• Time From Specimen Removal to Skin Closure

  Intraoperative (day of surgery)

• Total Operative Time

  Intraoperative (day of surgery)

• Cost-Effectiveness Analysis

  At study completion (after all participants have completed follow-up)

Study Arms (2)

Standard 2D Speciman Mammography (Control)

ACTIVE COMPARATOR

Participants undergo intraoperative specimen imaging using standard two-dimensional (2D) specimen mammography performed in the radiology department following tumour excision. The operating surgeon reviews the images intraoperatively to assess margin adequacy and determines whether additional excision is required prior to wound closure. All other aspects of surgical care follow standard institutional practice.

Procedure: Standard 2D Specimen Mammography

3D Digital Breast Tomosynthesis (Mozart System Intervention)

EXPERIMENTAL

Participants undergo intraoperative specimen imaging using three-dimensional (3D) digital breast tomosynthesis with the Mozart 3D Specimen Radiography System, performed directly in the operating theatre. The operating surgeon reviews reconstructed tomosynthesis images in real time to assess margin adequacy and determine whether additional excision is required prior to wound closure. All other aspects of surgical care remain unchanged.

Device: Mozart 3D Specimen Radiography System

Interventions

Standard 2D Specimen Mammography PROCEDURE

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.

Standard 2D Speciman Mammography (Control)

Mozart 3D Specimen Radiography System DEVICE

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.

3D Digital Breast Tomosynthesis (Mozart System Intervention)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult female patients undergoing breast-conserving surgery for primary breast cancer or ductal carcinoma in situ (DCIS) treated with curative intent at Beaumont Hospital.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Age ≥ 18 years
• Diagnosis of primary invasive breast cancer or ductal carcinoma in situ (DCIS) Planned breast-conserving surgery with curative intent No clinical or radiological evidence of distant metastatic disease at time of recruitment Able to provide written informed consent Fluent in English (spoken and written)

You may not qualify if:

• Evidence of metastatic (stage IV) breast cancer Planned mastectomy instead of breast-conserving surgery Prior ipsilateral breast cancer surgery for the current malignancy Inability to provide informed consent Participation in another interventional study that may affect surgical margin assessment

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI

CONTACT

018093000; adkhill@rcsi.com

Aisling Hegarty, PhD

CONTACT

Aislinghegarty@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intraoperative imaging intervention, surgeons and participants cannot be blinded to allocation. Final histopathological margin assessment will be performed by pathologists who are blinded to group allocation. Data analysts will also be blinded during primary outcome analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergoing breast-conserving surgery will be randomised in a 1:1 ratio to intraoperative margin assessment using either standard 2D specimen mammography (control group) or intraoperative 3D digital breast tomosynthesis using the Mozart system (intervention group). The assigned imaging modality will guide intraoperative decision-making regarding additional excision. Final histopathological assessment will be performed for all participants and analysed according to allocated group.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IE (1)