A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- MOLLI Localization Success Rate
研究概览
简要总结
The proposed trial is a non-randomized, multi-center, sequential arm registry evaluating clinical, and health economic outcomes following treatment with the Magnetic Occult Lesion Localization Instrument (MOLLI), an approved instrument for Breast Conserving Surgery (BCS) in patients with non-palpable lesions. All patients who have an area of concern in the breast and are identified by their physician as good candidates for BCS are eligible to participate. Patients will eventually be enrolled across 3 surgical sites (Sunnybrook Health Sciences Centre - primary site, Princess Margaret Cancer Centre, and North York General Hospital) over a 2 year period. Patient and system-related outcome measures will first be collected using the centre-specific standard of care (Wire-Guided Localization or Radioactive Seed Localization for BCS) to establish a baseline. Subsequently, centers will transition to the MOLLI system, recording corresponding outcomes to be used for temporal comparison. The overall objective of this study is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches.
详细描述
BACKGROUND INFORMATION
In contemporary breast cancer management, more than 70% of breast cancer patients are eligible for - and select - breast-conserving therapy (BCS). However, issues with cosmesis, patient experience, and treatment workflow efficiency during the therapeutic process have considerable room for improvement.
BCS consists of a surgical procedure whereby the suspicious tumor and a rim of surrounding normal tissue are removed. Up to one-third of all diagnosed breast cancers are non-palpable,and require some form of pre-operative localization to guide precise surgical excision. Currently, options for localization of non-palpable lesions are suboptimal in terms of patient experience, healthcare system resource utilization, and cost-effectiveness.
One of the most common approaches is radioactive seed localization (RSL). RSL consists of insertion of a small radioactive seed under ultrasound guidance to mark the center and/or borders of the tumor. During the procedure the surgeon uses a hand-held probe to detect the seed and guide surgical excision of the lesion intra-operatively. While RSL is effective the use of a radioactive source is and poses many challenges for patients and staff. Another common approach is wired-guided localization (WGL). WGL involves implantation of a hooked wire to mark the center or outer edges of the lesion. Due to modest cost and relative ease of use, WGL use is widespread, however disadvantages include significant patient discomfort, possible migration of the implanted wire, and potential difficulties in localizing axillary lymph nodes.
WHAT ARE THE INVESTIGATORS DOING?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older with histologically confirmed unifocal breast lesion and identified as a candidate for BCS, this includes patients with high-risk, premalignant (eg. ductal carcinoma in-situ), or malignant (eg. invasive ductal carcinoma) lesions
- •Lesions must be non-palpable and require pre-operative localization for surgical guidance
- •Lesions must be visible as determined by preoperative breast mammogram and / or ultrasound imaging. Pre-operative MRI is at the discretion of the treating surgeon.
排除标准
- •Biologically male patients
- •Locally advanced malignant breast cancer
- •Any absolute contraindications to BCS
- •Pregnancy or lactation
- •Existing allergy to metallic seed materials
- •Patients requiring MRI after MOLLI seed placement
结局指标
主要结局
MOLLI Localization Success Rate
时间窗: Day 3 (during surgical excision)
To determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance compared to standard of care approaches.
次要结局
- Cost-effectiveness of MOLLI(Day 1 (localization) and Day 3 (post surgery))
- Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression(Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up))
- Specimen Margin Positivity(Day 30)
- Duration of Implantation(Day 1 (localization))
- State-Trait Anxiety Inventory (STAI) to evaluate anxiety(Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up))
- Anxiety with Radiation(Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up))
- Re-excision rates(Day 30)
- Duration of Excision(Day 3 (during surgery))
研究者
Nicole Look Hong
Surgical Oncologist
Sunnybrook Health Sciences Centre