NCT07426809 Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).
| NCT ID | NCT07426809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 314 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 314 participants in total. It began in 2025-12-18 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07426809 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426809 currently recruiting?
Yes, NCT07426809 is actively recruiting participants. Contact the research team at adkhill@rcsi.com for enrollment information.
Where is the NCT07426809 trial being conducted?
This trial is being conducted at Beaumont, Ireland.
Who is sponsoring the NCT07426809 clinical trial?
NCT07426809 is sponsored by Royal College of Surgeons, Ireland. The trial plans to enroll 314 participants.
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