Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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, single-arm study examining the technical feasibility and safety of magnetic occult lesion localization and imaging (MOLLI) 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. All patients will undergo standard radioactive seed localization (RSL) for intraoperative surgical guidance concurrently with MOLLI localization. The feasibility trial will take place exclusively at a tertiary care institution (Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada) over a 1-year period. The primary endpoint of this study is to measure the success rate of localizing the MOLLI seed.
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.
WHAT ARE THE INVESTIGATORS DOING?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 cancer 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 between 1-5 cm in maximum dimensions to facilitate placement of seeds (either radioactive or metallic seeds for RSL or MOLLI procedures, respectively), as determined by preoperative breast mammogram and / or ultrasound imaging. Pre-operative MRI is at the discretion of the treating surgeon
- •The primary lesion must be visible on ultrasound OR mammogram
排除标准
- •Biologically male patients
- •Multifocal or multi-centric cancer requiring bracketing or multiple resections for complete excision
- •Locally advanced malignant breast cancer
- •Any absolute contraindications to BCS
- •Pregnancy or lactation
- •Unable or unwilling to undergo follow-up at Sunnybrook Health Sciences Centre
- •Prior allergy to magnetic seed components (nickel) or any part of the delivery system
结局指标
主要结局
MOLLI Localization Success Rate
时间窗: Day 3 post marker implantation (during surgical excision)
The primary goal of this study is to determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance alongside RSL.
次要结局
- Duration of Implantation(Day 0 (during marker implantation))
- Re-excision rates at 30 days(Day 30)
- Specimen Margin Positivity(Day 30)
- European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life(Day 0 (baseline), Day 30 (1 month FU))
- European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life(Day 0 (baseline), Day 30 (1 month FU))
- Duration of Excision(Day 3 (during surgery))
研究者
Ananth Ravi
Medical Physicist
Sunnybrook Health Sciences Centre