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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Uptake | Proportion of eligible women offered the study who consent to participate. | 12 months |
| Procedure Times | Time taken for each VAE procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Manchester | M13 9WU | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Participant will be given the option to consent to donating any surplus tumour tissue for use in other ethically approved studies.
| 12 months |
| Procedure pain and acceptability | 11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable | 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |