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

Breast Cancer Clinical Trial

— PICASSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679207
• Other study ID #: B00157
• Status: Completed
• Start date: June 25, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2023
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment Uptake	Proportion of eligible women offered the study who consent to participate.	12 months
Secondary	Procedure Times	Time taken for each VAE procedure.	12 months
Secondary	Procedure pain and acceptability	11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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