Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Rate f positive Surgical Margins
研究概览
简要总结
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.
详细描述
Below are ClinicalTrials.gov-ready versions of both sections. They follow plain-language guidance, avoid promotional tone, and avoid duplicating structured registry fields.
Brief Summary
(Plain-language, patient-facing; within 5,000 characters)
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
3D Digital Breast Tomosynthesis (Mozart System Intervention)
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.
干预措施: Mozart 3D Specimen Radiography System (Device)
Standard 2D Speciman Mammography (Control)
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.
干预措施: Standard 2D Specimen Mammography (Procedure)
结局指标
主要结局
Rate f positive Surgical Margins
时间窗: Within 4 weeks after index surgery (upon availability of final histopathology report)
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.
次要结局
- 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))