Ultrasound-guided vacuum-assisted excision of breast cancers
Research type
Research Study
Full title
A pilot study of ultrasound-guided vacuum-assisted excision of breast cancers (the PICASSO study)
IRAS ID
231898
Contact name
Anthony Maxwell
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study is designed to determine whether vacuum-assisted excision (VAE) under local anaesthetic is a safe and feasible way to remove small and medium sized invasive breast cancers in women who are unfit for, or refuse to undergo, surgical removal of the cancer. Currently many such women receive hormone treatment only. This may shrink the cancer but escape from hormone control often occurs, resulting in cancer regrowth. This typically occurs one to three years after diagnosis and can result either in uncontrollable disease or can force the need for surgery when the patient is older and usually more unfit than when she first presented.
This study aims to test the feasibility and safety of removing breast cancers up to 25 mm diameter in 20 such women. VAE is an outpatient needle biopsy procedure performed under local anaesthetic. It is currently used for pathological diagnosis of breast abnormalities and also for treatment of benign breast lumps such as fibroadenomas up to 40 mm in diameter. The procedure only takes a few minutes and involves injection of local anaesthetic into the skin and around the lump and insertion of the VAE needle through a skin incision about 6 mm in length. The lump is then removed piecemeal. The technique has proven to have few complications, the main one being bleeding. This is usually controllable by simple manual compression of the breast for a few minutes.
We plan to assess patient experience of the technique, its ability to remove the whole of the visible part of the cancer and to assess the size of any residual tumour at one and two years after the procedure to measure regrowth. An observational arm of women who decline the intervention but consent to provide data will be used as a comparator.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0168
Date of REC Opinion
6 Jun 2018
REC opinion
Further Information Favourable Opinion