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

NCT ID: NCT04679207

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2021-05-31

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

Exclusion Criteria

• The patient is on anticoagulants or has a known clotting disorder
• Pregnancy or lactation
• Allergy to local anaesthetic

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

B00157

Identifier Type: -

Identifier Source: org_study_id