Margin optimisation using real-time 3D tomosynthesis during breast-conserving surgery
Official title: Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).
Run by Royal College of Surgeons, Ireland · NCT07426809 · Data updated 2026-11-12
This trial will test whether using a portable 3D tomosynthesis device in the operating room helps surgeons find clear tissue margins during breast-conserving surgery compared with standard 2D specimen mammography.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 314 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Beaumont, Dublin) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07426809 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 or older with primary invasive breast cancer or ductal carcinoma in situ scheduled for breast-conserving surgery with curative intent and no known distant metastases who can provide informed consent.
✕Probably not a fit
Patients planning mastectomy, those with metastatic (stage IV) disease, or those with prior ipsilateral surgery for the current cancer are unlikely to benefit from this intraoperative margin-imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients undergoing breast-conserving surgery at Beaumont RCSI Cancer Centre are randomly assigned to intraoperative 3D specimen imaging with the Mozart system or to standard 2D specimen mammography. In the 3D arm the excised specimen is imaged in the operating theatre to provide depth (z-axis) information without moving the specimen to radiology, while the 2D arm follows current standard practice. The study compares margin status and rates of re-excision between groups, and records procedural time and workflow impacts. Results will indicate whether intraoperative tomosynthesis reduces additional operations and improves intraoperative decision-making.
Why it matters
Potential benefit: If successful, the approach could reduce the need for second operations by giving surgeons better real-time information about tumour margins.
How similar studies have gone: Previous small pilot studies and early reports have suggested intraoperative tomosynthesis can improve margin visualization compared with 2D imaging, but large randomized evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
-
Beaumont RCSI Cancer Centre
Beaumont, Dublin, Ireland Recruiting
Study contacts
- Study coordinator: Prof Arnold Hill, MB, BCh, BAO, MCh, FRCSI
- Email: adkhill@rcsi.com
- Phone: 018093000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.