PICASSO: A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Procedure pain and acceptability [12 months]
11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable
- 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).
- 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
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient is aged 18 years or older.
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Diagnosis on core needle biopsy of invasive cancer of the breast
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Unifocal invasive tumour on imaging (hormone receptor positive or negative)
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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)
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The tumour is clearly visible on ultrasound
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Vacuum-assisted excision of the entire ultrasonically visible tumour is deemed to be technically feasible
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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.
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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.
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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.
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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:
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The patient is on anticoagulants or has a known clotting disorder
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Pregnancy or lactation
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Allergy to local anaesthetic
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manchester University NHS Foundation Trust | Manchester | United Kingdom | M13 9WU |
Sponsors and Collaborators
- Manchester University NHS Foundation Trust
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B00157