NCT04679207已完成不适用
A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Greatest dimension of the Cancer
研究概览
简要总结
This study is looking into whether the procedure called Vacuum Assisted Excision (VAE) is a safe method for the removal of small and medium sized invasive breast cancers in patients who are unfit or have refused to have surgery to remove cancer.
Recruitment Target: 20
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient is aged 18 years or older.
- •Diagnosis on core needle biopsy of invasive cancer of the breast
- •Unifocal invasive tumour on imaging (hormone receptor positive or negative)
- •T1 or T2 primary or locally recurrent tumour measuring ≤25mm on imaging, excluding any adjacent ductal carcinoma in situ (largest of the measurements on mammography (including digital breast tomosynthesis if performed) and ultrasound)
- •The tumour is clearly visible on ultrasound
- •Vacuum-assisted excision of the entire ultrasonically visible tumour is deemed to be technically feasible
- •The patient is considered to be at high risk of complications or death from a general anaesthetic and therefore surgery under general anaesthesia is not considered appropriate. This must be confirmed by agreement by two named consultant breast surgeons, a multidisciplinary team meeting (including at least one consultant breast surgeon) or by formal anaesthetic assessment. Unsuitability for surgery under local anaesthetic must be confirmed by a consultant breast surgeon.
- •or - The patient refuses to undergo surgery. This must be confirmed by a consultant surgeon and breast care nurse following full discussion of the treatment options.
- •or - The patient is considered unlikely to benefit from surgical removal of the cancer by virtue of known metastatic disease or other life-shortening condition. This must be confirmed by discussion in a multidisciplinary team meeting which includes an oncologist.
- •The patient has given written informed consent for the study Women who are already on primary endocrine therapy for a breast cancer and meet the inclusion criteria will also be eligible.
排除标准
- •The patient is on anticoagulants or has a known clotting disorder
- •Pregnancy or lactation
- •Allergy to local anaesthetic
结局指标
主要结局
Greatest dimension of the Cancer
时间窗: 1 year
The proportion of participants in whom the greatest dimension of the cancer on imaging at 1 year post-vacuum assisted excision (VAE) is ≤50% of its pre-VAE size.
次要结局
- Complication rate of VAE(12 months)
- Recruitment Uptake(12 months)
- Procedure Times(12 months)
- Proportion of Cancer removed(12 months)
- Procedure pain and acceptability(12 months)
- proportion willing to undergo the procedure again if necessary.(12 months)
- Requirement of salvage surgery(2 years post VAE)
- Residual Cancer after VAE(2 years post VAE)
- Histopathology of cavity walls(Imaging at 1 year and 2 years.)
研究者
研究点 (1)
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