A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers

Study Overview
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Brief Summary
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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

Official Title
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A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Vacuum-assisted excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: The patient is on anticoagulants or has a known clotting disorder Pregnancy or lactation Allergy to local anaesthetic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Vacuum-assisted excision|Vacuum-assisted biopsy (VAB) is a minimally invasive technique performed under local anaesthetic as an outpatient procedure by radiologists using x-ray or ultrasound guidance. It was developed in the USA in the mid 1990s and has become well established as a diagnostic test for suspected breast disease. It uses the combination of a large gauge biopsy needle and suction to allow larger pieces of tissue to be removed than can be obtained with a standard needle biopsy device. The technique is used widely for diagnostic purposes and, in some centres, for the therapeutic removal of benign breast lumps such as fibroadenomas and papillomas.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greatest dimension of the Cancer | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Uptake | Proportion of eligible women offered the study who consent to participate. | 12 months | 
| Procedure Times | Time taken for each VAE procedure. | 12 months | 
| Procedure pain and acceptability | 11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable | 12 months | 
| Complication rate of VAE | Proportion of women who have significant bleeding after the procedure (defined as bleeding requiring > 20 minutes manual compression to control and/or a haematoma requiring aspiration or surgical evacuation) or infection at the VAE site (defined as requiring antibiotic treatment and/or an abscess requiring aspiration or surgery). | 12 months | 
| Proportion of Cancer removed | Proportion of women in whom the cancer appears to be completely removed as judged on ultrasound at the end of the VAE procedure | 12 months | 
| Residual Cancer after VAE | Proportion of participants in whom the greatest dimension of the cancer on imaging at 2 years post-VAE is less ≤ 50% of its pre-VAE size. | 2 years post VAE | 
| Requirement of salvage surgery | Proportion of participants who undergo surgery to the ipsilateral breast within 2 years of the VAE procedure because of continued growth of the tumour. | 2 years post VAE | 
| Histopathology of cavity walls | Proportion of participants with positive and negative cavity wall biopsies respectively who have tumour visible on imaging at 1 and 2 years. | Imaging at 1 year and 2 years. | 
| proportion willing to undergo the procedure again if necessary. | proportion willing to undergo the procedure again if necessary based on yes or no question | 12 months |