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

NCT04679207 | Completed

• 1 other identifier: B00157
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Recruitment Uptake

  12 months

• Procedure Times

  12 months

• Procedure pain and acceptability

  12 months

• Complication rate of VAE

  12 months

• Proportion of Cancer removed

  12 months

Interventions

Vacuum-assisted excision PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who require 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participant will be given the option to consent to donating any surplus tumour tissue for use in other ethically approved studies.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 22, 2020
• Study Start: June 25, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

GB (1)