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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04679207
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-25
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Greatest dimension of the Cancer	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.

Secondary Outcome Measures

Name	Time	Method
Complication rate of VAE	12 months	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).
Recruitment Uptake	12 months	Proportion of eligible women offered the study who consent to participate.
Procedure Times	12 months	Time taken for each VAE procedure.
Proportion of Cancer removed	12 months	Proportion of women in whom the cancer appears to be completely removed as judged on ultrasound at the end of the VAE procedure
Procedure pain and acceptability	12 months	11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable
proportion willing to undergo the procedure again if necessary.	12 months	proportion willing to undergo the procedure again if necessary based on yes or no question
Residual Cancer after VAE	2 years post 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.
Requirement of salvage surgery	2 years post VAE	Proportion of participants who undergo surgery to the ipsilateral breast within 2 years of the VAE procedure because of continued growth of the tumour.
Histopathology of cavity walls	Imaging at 1 year and 2 years.	Proportion of participants with positive and negative cavity wall biopsies respectively who have tumour visible on imaging at 1 and 2 years.

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom