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

A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Vacuum-assisted excision

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WU
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: B00157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No