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

NHS Foundation Trust

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Vacuum-assisted excision

Study type: Observational

Funder types: Other

Identifiers

NCT04679207

B00157

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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