Last reviewed · How we verify
NCT07426809: MOZART
Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).
NA trial testing Standard 2D Specimen Mammography in Breast Cancer in 314 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Royal College of Surgeons, Ireland |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 314 |
| Start date | 18 December 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- Standard 2D Specimen Mammography
- Mozart 3D Specimen Radiography System
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Royal College of Surgeons, Ireland
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07426809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Royal College of Surgeons, Ireland trials
Trials by the same sponsor.
- NCT07443579 — Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography · NA · recruiting
- NCT07426861 — Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence · NA · recruiting
- NCT07426835 — The PHARO Trial: The Incidence of Para-conduit Hernia With Closure of Hiatus Versus the Standard Approach in Robotic Oes · NA · recruiting
- NCT07426848 — OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients · NA · recruiting
- NCT07426874 — eHealth Support Tool to Improve Quality of Life in Head and Neck Cancer Survivors · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07426809 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royal College of Surgeons, Ireland
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07426809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing